ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
This device is manufactured by MEDTRONIC MINIMED, MEDTRONIC PUERTO RICO OPERATIONS CO.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2023-07-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Cycle |
| 2019-09-10 | Injury | None | Device Alarm System, Obstruction of Flow, Battery Problem, Patient Device Interaction Problem |
| 2019-09-06 | Malfunction | None | Display or Visual Feedback Problem, Mechanical Problem, Device Difficult to Program or Calibrate, Battery Problem |
| 2019-09-03 | Malfunction | None | Premature Discharge of Battery |
| 2019-08-30 | Malfunction | None | Device Alarm System, Device Difficult to Program or Calibrate, Battery Problem, Patient Device Interaction Problem |
| 2019-08-30 | Malfunction | None | Device Alarm System, Mechanical Problem, Obstruction of Flow, Battery Problem, Power Problem, Appropriate Term/Code Not Available, Patient Device Interaction Problem |
| 2019-08-29 | Malfunction | None | Device Difficult to Program or Calibrate, Obstruction of Flow, Battery Problem |
| 2019-08-26 | Malfunction | None | Mechanical Problem, Insufficient Information |
| 2019-08-26 | Injury | None | Obstruction of Flow, No Apparent Adverse Event |
| 2019-08-22 | Malfunction | None | Mechanical Problem |
| 2019-08-19 | Malfunction | None | Patient Device Interaction Problem |
| 2019-08-14 | Malfunction | None | Device Difficult to Program or Calibrate, Patient Device Interaction Problem |
| 2019-08-12 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2019-08-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-29 | Malfunction | None | Patient Device Interaction Problem |
| 2019-07-22 | Malfunction | None | Failure to Cycle |
| 2019-07-18 | Malfunction | None | Device Difficult to Program or Calibrate, Obstruction of Flow, Priming Problem |
| 2019-07-04 | Injury | None | Failure to Cycle |
| 2019-07-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-02 | Malfunction | None | Device Difficult to Program or Calibrate, Obstruction of Flow, Battery Problem, Patient Device Interaction Problem |
| 2019-06-30 | Malfunction | None | Computer Software Problem, Application Program Version or Upgrade Problem |
| 2019-06-15 | Malfunction | None | Mechanical Problem |
| 2019-06-13 | Malfunction | None | Display or Visual Feedback Problem, Device Difficult to Program or Calibrate, Patient Device Interaction Problem |
| 2019-06-12 | Malfunction | None | No Display/Image, Patient Device Interaction Problem |
| 2019-06-12 | Malfunction | None | Premature Discharge of Battery, No Display/Image |
| 2019-06-12 | Malfunction | None | Failure to Cycle |
| 2019-06-11 | Malfunction | None | Connection Problem, Power Problem |
| 2019-06-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-30 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2019-05-29 | Malfunction | None | Connection Problem, Patient Device Interaction Problem |
| 2019-05-29 | Malfunction | None | Mechanical Problem, Obstruction of Flow, Power Problem, Patient Device Interaction Problem |
| 2019-05-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-25 | Injury | None | Patient Device Interaction Problem |
| 2019-05-20 | Malfunction | None | Mechanical Problem |
| 2019-05-19 | Malfunction | None | Mechanical Problem |
| 2019-05-19 | Malfunction | None | Failure to Cycle |
| 2019-05-17 | Malfunction | None | Failure to Cycle |
| 2019-05-11 | Malfunction | None | Mechanical Problem |
| 2019-05-08 | Malfunction | None | Material Integrity Problem |
| 2019-05-07 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2019-05-07 | Malfunction | None | Unexpected Therapeutic Results |
| 2019-05-04 | Malfunction | None | Failure to Cycle, No Apparent Adverse Event |
| 2019-05-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-02 | Injury | None | Premature Discharge of Battery, No Apparent Adverse Event |
| 2019-05-02 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2019-05-02 | Malfunction | None | Premature Discharge of Battery, Mechanical Problem, Obstruction of Flow |
| 2019-05-01 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2019-05-01 | Injury | None | Obstruction of Flow, Priming Problem |
| 2019-04-25 | Malfunction | None | No Display/Image, Moisture or Humidity Problem, Insufficient Information |
| 2019-04-25 | Malfunction | None | Display or Visual Feedback Problem, Device Difficult to Program or Calibrate |
| 2019-04-20 | Injury | None | Obstruction of Flow |
| 2019-04-18 | Malfunction | None | Premature Discharge of Battery, Device Difficult to Program or Calibrate, Obstruction of Flow |
| 2019-04-17 | Injury | None | Battery Problem, No Apparent Adverse Event |
| 2019-04-16 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2019-04-16 | Malfunction | None | Device Alarm System |
| 2019-04-14 | Malfunction | None | Premature Discharge of Battery, Device Difficult to Program or Calibrate, Connection Problem, Patient Device Interaction Problem |
| 2019-04-14 | Injury | None | Device Difficult to Program or Calibrate |
| 2019-04-10 | Injury | None | Premature Discharge of Battery, Appropriate Term/Code Not Available |
| 2019-04-09 | Malfunction | None | Device Alarm System |
| 2019-04-09 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2019-04-09 | Malfunction | None | Use of Device Problem, Patient Device Interaction Problem |
| 2019-04-09 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-04-09 | Malfunction | None | Mechanical Problem, Device Difficult to Program or Calibrate, Patient Device Interaction Problem |
| 2019-04-07 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2019-04-05 | Malfunction | None | Mechanical Problem |
| 2019-04-04 | Injury | None | Display or Visual Feedback Problem, Use of Device Problem, Obstruction of Flow, No Apparent Adverse Event |
| 2019-04-03 | Malfunction | None | Use of Device Problem, Obstruction of Flow, Power Problem, Patient Device Interaction Problem |
| 2019-04-03 | Injury | None | Device Difficult to Program or Calibrate, Obstruction of Flow, Battery Problem, Patient Device Interaction Problem |
| 2019-04-02 | Malfunction | None | Use of Device Problem, Obstruction of Flow, Power Problem, Patient Device Interaction Problem |
| 2019-03-25 | Malfunction | None | Mechanical Problem, Device Difficult to Program or Calibrate, Patient Device Interaction Problem |
| 2019-03-25 | Malfunction | None | Device Difficult to Program or Calibrate, Obstruction of Flow, Battery Problem, Patient Device Interaction Problem |
| 2019-03-18 | Malfunction | None | Mechanical Problem, Patient Device Interaction Problem |
| 2019-03-13 | Malfunction | None | Device Difficult to Program or Calibrate, Obstruction of Flow |
| 2019-03-13 | Malfunction | None | Connection Problem, Patient Device Interaction Problem |
| 2019-03-13 | Malfunction | None | Device Difficult to Program or Calibrate, Obstruction of Flow |
| 2019-03-07 | Injury | None | Mechanical Problem, Appropriate Term/Code Not Available |
| 2019-03-06 | Malfunction | None | Obstruction of Flow, Battery Problem, Power Problem, No Apparent Adverse Event, Patient Device Interaction Problem |
| 2019-03-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-04 | Malfunction | None | Patient Device Interaction Problem |
| 2019-02-28 | Malfunction | None | Premature Discharge of Battery |
| 2019-02-28 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-02-27 | Injury | None | Premature Discharge of Battery, No Display/Image, Battery Problem, No Apparent Adverse Event, Unexpected Shutdown |
| 2019-02-26 | Injury | None | Mechanical Problem, No Apparent Adverse Event |
| 2019-02-26 | Malfunction | None | Patient Device Interaction Problem |
| 2019-02-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-20 | Malfunction | None | Device Alarm System, Mechanical Problem, Battery Problem, Power Problem |
| 2019-02-18 | Malfunction | None | Premature Discharge of Battery, Mechanical Problem, Patient Device Interaction Problem, Priming Problem |
| 2019-02-18 | Malfunction | None | Device Difficult to Program or Calibrate, Patient Device Interaction Problem |
| 2019-02-18 | Malfunction | None | Device Difficult to Program or Calibrate, Obstruction of Flow |
| 2019-02-17 | Malfunction | None | Power Problem |
| 2019-02-13 | Malfunction | None | Display or Visual Feedback Problem |
| 2019-02-13 | Malfunction | None | Connection Problem, Patient Device Interaction Problem |
| 2019-02-05 | Malfunction | None | Display or Visual Feedback Problem, Mechanical Problem |
| 2019-02-05 | Malfunction | None | Premature Discharge of Battery, Wireless Communication Problem |
| 2019-02-04 | Malfunction | None | Device Difficult to Program or Calibrate, Obstruction of Flow, Patient Device Interaction Problem |
| 2019-02-01 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2019-01-30 | Malfunction | None | Display or Visual Feedback Problem, Mechanical Problem, Device Difficult to Program or Calibrate, Obstruction of Flow, Material Integrity Problem, Patient Device Interaction Problem, Priming Problem |
| 2019-01-29 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2019-01-26 | Malfunction | None | Premature Discharge of Battery, No Apparent Adverse Event, Patient Device Interaction Problem |
| 2019-01-25 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2019-01-23 | Malfunction | None | Mechanical Problem, Device Difficult to Program or Calibrate, Power Problem |
| 2019-01-15 | Malfunction | None | Priming Problem |
| 2019-01-14 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2019-01-07 | Malfunction | None | Premature Discharge of Battery, Adverse Event Without Identified Device or Use Problem, Power Problem |
| 2019-01-04 | Malfunction | None | Premature Discharge of Battery, No Display/Image, Device Difficult to Program or Calibrate, Power Problem |
| 2019-01-04 | Malfunction | None | Connection Problem, Patient Device Interaction Problem |
| 2019-01-03 | Malfunction | None | Patient Device Interaction Problem |
| 2019-01-03 | Malfunction | None | Adverse Event Without Identified Device or Use Problem, Power Problem, Priming Problem |
| 2019-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2018-12-25 | Malfunction | None | No Display/Image, Device Difficult to Program or Calibrate, Material Integrity Problem, Power Problem |
| 2018-12-21 | Malfunction | None | Device Alarm System, Device Difficult to Program or Calibrate, Power Problem |
| 2018-12-21 | Malfunction | None | Failure to Cycle |
| 2018-12-20 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2018-12-17 | Malfunction | None | Device Difficult to Program or Calibrate, Patient Device Interaction Problem |
| 2018-12-17 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2018-12-15 | Malfunction | None | Mechanical Problem, Obstruction of Flow, Power Problem |
| 2018-12-11 | Malfunction | None | Mechanical Problem, Power Problem, Priming Problem |
| 2018-12-04 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2018-12-01 | Malfunction | None | Failure to Cycle |
| 2018-11-30 | Malfunction | None | Premature Discharge of Battery |
| 2018-11-27 | Malfunction | None | No Display/Image |
| 2018-11-26 | Malfunction | None | Device Difficult to Program or Calibrate, Obstruction of Flow, Communication or Transmission Problem, Power Problem, Insufficient Information |
| 2018-11-22 | Injury | None | Device Difficult to Program or Calibrate, Visual Prompts will not Clear, No Apparent Adverse Event |
| 2018-11-22 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2018-11-19 | Malfunction | None | Patient Device Interaction Problem |
| 2018-11-09 | Malfunction | None | Device Difficult to Program or Calibrate, Obstruction of Flow, Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2018-11-05 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2018-11-05 | Malfunction | None | No Display/Image, Power Problem |
| 2018-11-03 | Malfunction | None | No Display/Image |
| 2018-11-01 | Malfunction | None | Patient Device Interaction Problem |
| 2018-10-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-30 | Malfunction | None | Patient Device Interaction Problem |
| 2018-10-30 | Malfunction | None | Device Difficult to Program or Calibrate, Patient Device Interaction Problem |
| 2018-10-27 | Malfunction | None | No Display/Image |
| 2018-10-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-23 | Malfunction | None | No Display/Image, Patient Device Interaction Problem |
| 2018-10-23 | Malfunction | None | Power Problem, Priming Problem |
| 2018-10-19 | Injury | None | Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event |
| 2018-10-18 | Malfunction | None | Device Alarm System |
| 2018-10-12 | Malfunction | None | Failure to Cycle |
| 2018-10-11 | Malfunction | None | Mechanical Problem |
| 2018-10-10 | Malfunction | None | Appropriate Term/Code Not Available |
| 2018-10-09 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2018-10-09 | Malfunction | None | Power Problem |
| 2018-10-08 | Malfunction | None | Power Problem |
| 2018-10-04 | Injury | None | Device Alarm System |
| 2018-10-03 | Injury | None | Material Integrity Problem |
| 2018-10-03 | Malfunction | None | Priming Problem |
| 2018-10-01 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2018-10-01 | Malfunction | None | Patient Device Interaction Problem |
| 2018-10-01 | Malfunction | None | Mechanical Problem |
| 2018-09-24 | Malfunction | None | Power Problem |
| 2018-09-22 | Injury | None | Power Problem |
| 2018-09-17 | Malfunction | None | Obstruction of Flow |
| 2018-09-17 | Malfunction | None | Obstruction of Flow |
| 2018-09-11 | Malfunction | None | Power Problem |
| 2018-09-08 | Injury | None | No Apparent Adverse Event |
| 2018-09-07 | Malfunction | None | Patient Device Interaction Problem |
| 2018-09-05 | Malfunction | None | Mechanical Problem |
| 2018-09-05 | Malfunction | None | Power Problem |
| 2018-09-04 | Injury | None | Power Problem |
| 2018-09-04 | Malfunction | None | No Display/Image |
| 2018-09-02 | Injury | None | No Apparent Adverse Event |
| 2018-09-01 | Injury | None | No Apparent Adverse Event |
| 2018-09-01 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2018-09-01 | Malfunction | None | Priming Problem |
| 2018-08-31 | Malfunction | None | Patient Device Interaction Problem |
| 2018-08-28 | Injury | None | No Apparent Adverse Event |
| 2018-08-28 | Injury | None | No Apparent Adverse Event |
| 2018-08-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-26 | Malfunction | None | Failure to Cycle |
| 2018-08-22 | Malfunction | None | Power Problem |
| 2018-08-22 | Malfunction | None | Mechanical Problem |
| 2018-08-21 | Malfunction | None | Device Difficult to Program or Calibrate, Patient Device Interaction Problem |
| 2018-08-16 | Injury | None | Patient Device Interaction Problem |
| 2018-08-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-13 | Malfunction | None | Failure to Cycle |
| 2018-08-07 | Malfunction | None | Appropriate Term/Code Not Available |
| 2018-08-06 | Malfunction | None | Patient Device Interaction Problem |
| 2018-08-05 | Malfunction | None | Patient Device Interaction Problem, Priming Problem |
| 2018-08-05 | Malfunction | None | No Apparent Adverse Event, Priming Problem |
| 2018-08-02 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2018-07-31 | Malfunction | None | Premature Discharge of Battery, No Display/Image, Power Problem, Patient Device Interaction Problem |
| 2018-07-31 | Malfunction | None | Patient Device Interaction Problem |
| 2018-07-30 | Malfunction | None | Appropriate Term/Code Not Available |
| 2018-07-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-27 | Malfunction | None | Failure to Cycle |
| 2018-07-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-22 | Malfunction | None | Obstruction of Flow |
| 2018-07-21 | Malfunction | None | Obstruction of Flow |
| 2018-07-19 | Malfunction | None | Detachment of Device or Device Component |
| 2018-07-17 | Malfunction | None | Device Difficult to Program or Calibrate, Appropriate Term/Code Not Available, Patient Device Interaction Problem |
| 2018-07-17 | Injury | None | No Apparent Adverse Event |
| 2018-07-16 | Malfunction | None | Device Difficult to Program or Calibrate, Material Integrity Problem |
| 2018-07-16 | Malfunction | None | Power Problem |
| 2018-07-15 | Injury | None | Moisture or Humidity Problem |
| 2018-07-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-14 | Injury | None | Appropriate Term/Code Not Available |
| 2018-07-12 | Malfunction | None | Mechanical Problem |
| 2018-07-12 | Malfunction | None | Obstruction of Flow |
| 2018-07-10 | Malfunction | None | Power Problem |
| 2018-07-10 | Malfunction | None | Appropriate Term/Code Not Available |
| 2018-07-10 | Injury | None | Device Alarm System |
| 2018-07-10 | Malfunction | None | Failure to Cycle |
| 2018-07-08 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-06 | Malfunction | None | Patient Device Interaction Problem |
| 2018-07-06 | Malfunction | None | No Display/Image |
| 2018-07-03 | Injury | None | Unexpected Therapeutic Results |
| 2018-07-03 | Malfunction | None | Patient Device Interaction Problem |
| 2018-07-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-01 | Injury | None | Appropriate Term/Code Not Available |
| 2018-06-29 | Malfunction | None | No Display/Image |
| 2018-06-29 | Malfunction | None | Premature Discharge of Battery |
| 2018-06-29 | Malfunction | None | Mechanical Problem, Human-Device Interface Problem |
| 2018-06-27 | Injury | None | Obstruction of Flow |
| 2018-06-25 | Malfunction | None | Obstruction of Flow |
| 2018-06-25 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2018-06-25 | Malfunction | None | Human-Device Interface Problem |
| 2018-06-23 | Injury | None | Patient Device Interaction Problem |
| 2018-06-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-20 | Malfunction | None | Appropriate Term/Code Not Available |
| 2018-06-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-17 | Malfunction | None | Failure to Cycle |
| 2018-06-16 | Malfunction | None | Appropriate Term/Code Not Available |
| 2018-06-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-12 | Malfunction | None | Device Alarm System |
| 2018-06-12 | Injury | None | Appropriate Term/Code Not Available |
| 2018-06-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-03 | Injury | None | No Display/Image |
| 2018-06-02 | Injury | None | Detachment Of Device Component |
| 2018-05-30 | Malfunction | None | Mechanical Problem, Device Difficult to Program or Calibrate, Insufficient Information, Appropriate Term/Code Not Available |
| 2018-05-29 | Injury | None | Appropriate Term/Code Not Available |
| 2018-05-29 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2018-05-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-25 | Malfunction | None | Device Alarm System |
| 2018-05-20 | Malfunction | None | Device Displays Incorrect Message, Material Protrusion/Extrusion |
| 2018-05-19 | Malfunction | None | Device Displays Incorrect Message |
| 2018-05-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-18 | Malfunction | None | Improper Flow or Infusion |
| 2018-05-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-15 | Injury | None | No Display/Image |
| 2018-05-13 | Malfunction | None | Device Displays Incorrect Message |
| 2018-05-10 | Malfunction | None | Premature Discharge of Battery |
| 2018-05-09 | Malfunction | None | Loss of Power |
| 2018-05-09 | Injury | None | Reset Problem |
| 2018-05-09 | Injury | None | Device Displays Incorrect Message |
| 2018-05-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-05 | Malfunction | None | Battery Problem |
| 2018-05-01 | Malfunction | None | Premature Discharge of Battery, Failure to Cycle, Patient Device Interaction Problem |
| 2018-04-29 | Injury | None | Device Inoperable |
| 2018-04-26 | Injury | None | Device Alarm System |
| 2018-04-25 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-04-23 | Injury | None | Device Slipped |
| 2018-04-23 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2018-04-22 | Malfunction | None | No Display/Image |
| 2018-04-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-18 | Injury | None | Insufficient Flow or Under Infusion |
| 2018-04-17 | Malfunction | None | Device Displays Incorrect Message |
| 2018-04-12 | Injury | None | Insufficient Information |
| 2018-04-12 | Injury | None | Connection Problem |
| 2018-04-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-09 | Malfunction | None | Human-Device Interface Problem |
| 2018-04-02 | Injury | None | Device Displays Incorrect Message |
| 2018-04-01 | Malfunction | None | Display or Visual Feedback Problem, Connection Problem, Patient Device Interaction Problem |
| 2018-03-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-03-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-28 | Malfunction | None | Device Displays Incorrect Message |
| 2018-03-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-24 | Injury | None | Bent |
| 2018-03-22 | Injury | None | High Test Results |
| 2018-03-20 | Malfunction | None | Device Displays Incorrect Message |
| 2018-03-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-18 | Injury | None | Device Inoperable |
| 2018-03-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-09 | Injury | None | Detachment Of Device Component |
| 2018-03-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-04 | Injury | None | No Display/Image |
| 2018-03-04 | Malfunction | None | Power Problem |
| 2018-03-03 | Malfunction | None | Device Displays Incorrect Message |
| 2018-03-02 | Malfunction | None | Device Difficult to Program or Calibrate |
| 2018-02-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-21 | Injury | None | Device Displays Incorrect Message |
| 2018-02-20 | Malfunction | None | Device Displays Incorrect Message |
| 2018-02-20 | Malfunction | None | Break, Crack, Device Slipped, Charging Problem |
| 2018-02-18 | Malfunction | None | Break, Component Missing, Material Deformation |
| 2018-02-16 | Malfunction | None | Component Missing |
| 2018-02-15 | Malfunction | None | Device Displays Incorrect Message |
| 2018-02-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-12 | Malfunction | None | No Display/Image, Component Missing, Device Displays Incorrect Message |
| 2018-02-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-28 | Injury | None | Insufficient Flow or Under Infusion |
| 2018-01-21 | Malfunction | None | No Display/Image |
| 2018-01-21 | Malfunction | None | No Display/Image, Device Displays Incorrect Message |
| 2018-01-17 | Injury | None | Break, Detachment Of Device Component |
| 2018-01-16 | Malfunction | None | Device Alarm System, Inaccurate Delivery |
| 2018-01-15 | Injury | None | Failure to Deliver, High Test Results, Device Displays Incorrect Message |
| 2018-01-15 | Malfunction | None | Incorrect Or Inadequate Test Results, Device Displays Incorrect Message |
| 2018-01-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-01-13 | Injury | None | Device Displays Incorrect Message |
| 2018-01-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-11 | Malfunction | None | Communication or Transmission Problem |
| 2018-01-09 | Injury | None | Insufficient Information |
| 2018-01-07 | Malfunction | None | Device Alarm System, Fluid/Blood Leak, Looping, Material Protrusion/Extrusion |
| 2018-01-06 | Malfunction | None | Failure to Power Up |
| 2018-01-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-05 | Injury | None | Low Test Results |
| 2018-01-02 | Malfunction | None | Device Displays Incorrect Message |
| 2017-12-26 | Injury | None | Disconnection |
| 2017-12-26 | Injury | None | High Test Results, Low Test Results |
| 2017-12-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-25 | Injury | None | Insufficient Information |
| 2017-12-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-25 | Injury | None | Electromagnetic Interference, Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected |
| 2017-12-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-18 | Injury | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-12-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-12 | Malfunction | None | Crack, Device Displays Incorrect Message |
| 2017-12-12 | Injury | None | Short Fill, Device Displays Incorrect Message |
| 2017-12-08 | Malfunction | None | No Display/Image |
| 2017-12-08 | Malfunction | None | No Display/Image, Device Stops Intermittently |
| 2017-12-04 | Injury | None | Insufficient Information |
| 2017-12-04 | Injury | None | High Test Results |
| 2017-12-03 | Injury | None | Insufficient Flow or Under Infusion |
| 2017-12-01 | Malfunction | None | Device Displays Incorrect Message |
| 2017-11-30 | Malfunction | None | No Display/Image |
| 2017-11-28 | Injury | None | Low Test Results, Material Protrusion/Extrusion |
| 2017-11-24 | Injury | None | Insufficient Flow or Under Infusion |
| 2017-11-23 | Malfunction | None | Break, Loose or Intermittent Connection |
| 2017-11-17 | Injury | None | Device Displays Incorrect Message, Material Protrusion/Extrusion |
| 2017-11-15 | Malfunction | None | Break, Detachment Of Device Component |
| 2017-11-14 | Malfunction | None | Crack |
| 2017-11-12 | Malfunction | None | Insufficient Flow or Under Infusion |
| 2017-11-11 | Malfunction | None | Break |
| 2017-11-10 | Injury | None | Device Displays Incorrect Message |
| 2017-11-09 | Injury | None | Insufficient Information |
| 2017-11-08 | Injury | None | Device Displays Incorrect Message |
| 2017-11-08 | Malfunction | None | Device Displays Incorrect Message |
| 2017-11-07 | Malfunction | None | Device Displays Incorrect Message |
| 2017-11-06 | Malfunction | None | Break |
| 2017-11-04 | Injury | None | Sticking |
| 2017-11-02 | Malfunction | None | Fluid/Blood Leak, Excess Flow or Over-Infusion, Sticking, Device Operates Differently Than Expected |
| 2017-11-02 | Injury | None | High Test Results, Low Battery, Device Displays Incorrect Message, Failure of Device to Self-Test |
| 2017-11-02 | Malfunction | None | Detachment Of Device Component, Loose or Intermittent Connection |
| 2017-10-31 | Malfunction | None | Device Displays Incorrect Message, Reset Problem |
| 2017-10-28 | Injury | None | High Test Results, Battery Problem |
| 2017-10-28 | Injury | None | Insufficient Information |
| 2017-10-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-27 | Injury | None | Insufficient Information |
| 2017-10-26 | Injury | None | Bent |
| 2017-10-25 | Injury | None | Break |
| 2017-10-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-23 | Malfunction | None | Device Displays Incorrect Message |
| 2017-10-21 | Injury | None | Insufficient Information |
| 2017-10-20 | Injury | None | Insufficient Information |
| 2017-10-17 | Injury | None | Device Operates Differently Than Expected |
| 2017-10-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-15 | Injury | None | High Readings, Device Displays Incorrect Message |
| 2017-10-15 | Malfunction | None | Break |
| 2017-10-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-14 | Injury | None | Insufficient Information |
| 2017-10-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-13 | Malfunction | None | No Display/Image |
| 2017-10-11 | Injury | None | Dent in Material |
| 2017-10-09 | Injury | None | No Display/Image, Failure to Power Up |
| 2017-10-08 | Malfunction | None | Material Erosion, Mechanics Altered |
| 2017-10-07 | Injury | None | Appropriate Term/Code Not Available |
| 2017-10-05 | Malfunction | None | Failure to Deliver, Device Displays Incorrect Message |
| 2017-10-03 | Malfunction | None | Break, Structural Problem |
| 2017-10-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-28 | Malfunction | None | Crack, Low Readings |
| 2017-09-28 | Malfunction | None | Device Displays Incorrect Message |
| 2017-09-25 | Malfunction | None | Obstruction of Flow, No Apparent Adverse Event |
| 2017-09-24 | Malfunction | None | Device Displays Incorrect Message |
| 2017-09-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-24 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-09-22 | Malfunction | None | Break, Component Falling, No Display/Image, Device Displays Incorrect Message, Battery Problem, Scratched Material |
| 2017-09-18 | Injury | None | Device Inoperable |
| 2017-09-17 | Malfunction | None | Device Displays Incorrect Message |
| 2017-09-16 | Injury | None | Device Displays Incorrect Message |
| 2017-09-15 | Injury | None | Insufficient Information |
| 2017-09-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-15 | Injury | None | Insufficient Information |
| 2017-09-14 | Injury | None | Device Operates Differently Than Expected |
| 2017-09-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-07 | Malfunction | None | Leak/Splash |
| 2017-09-06 | Malfunction | None | Device Displays Incorrect Message |
| 2017-09-05 | Injury | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-09-03 | Injury | None | Material Protrusion/Extrusion |
| 2017-09-02 | Injury | None | No Display/Image |
| 2017-09-01 | Injury | None | Difficult or Delayed Positioning, Defective Component |
| 2017-09-01 | Injury | None | Insufficient Information |
| 2017-08-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-30 | Malfunction | None | Break, Detachment Of Device Component |
| 2017-08-25 | Malfunction | None | Fluid/Blood Leak, Device Displays Incorrect Message |
| 2017-08-25 | Malfunction | None | Break |
| 2017-08-24 | Injury | None | Detachment Of Device Component, High Test Results |
| 2017-08-23 | Injury | None | Device Displays Incorrect Message |
| 2017-08-22 | Injury | None | No Display/Image |
| 2017-08-22 | Malfunction | None | No Display/Image |
| 2017-08-22 | Injury | None | Insufficient Information |
| 2017-08-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-18 | Injury | None | Device Displays Incorrect Message |
| 2017-08-16 | Injury | None | Insufficient Information |
| 2017-08-14 | Malfunction | None | Device Displays Incorrect Message |
| 2017-08-14 | Malfunction | None | Device Displays Incorrect Message |
| 2017-08-14 | Malfunction | None | Device Displays Incorrect Message, Material Protrusion/Extrusion |
| 2017-08-13 | Malfunction | None | No Display/Image |
| 2017-08-12 | Malfunction | None | Poor Quality Image |
| 2017-08-12 | Injury | None | Improper or Incorrect Procedure or Method |
| 2017-08-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-10 | Malfunction | None | No Display/Image, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-08-08 | Injury | None | Occlusion Within Device, Device Displays Incorrect Message |
| 2017-08-08 | Malfunction | None | Break, Component Missing |
| 2017-08-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-01 | Injury | None | Appropriate Term/Code Not Available |
| 2017-08-01 | Malfunction | None | Break, Component Falling, No Display/Image |
| 2017-08-01 | Injury | None | Nonstandard Device, Low Test Results |
| 2017-07-26 | Malfunction | None | Device Displays Incorrect Message, Improper Flow or Infusion |
| 2017-07-26 | Malfunction | None | Patient Device Interaction Problem |
| 2017-07-24 | Injury | None | Component Missing |
| 2017-07-24 | Malfunction | None | Incorrect Or Inadequate Test Results, Device Displays Incorrect Message |
| 2017-07-24 | Malfunction | None | Inappropriate or Unexpected Reset |
| 2017-07-22 | Injury | None | Connection Problem |
| 2017-07-18 | Injury | None | Insufficient Information |
| 2017-07-10 | Malfunction | None | Break |
| 2017-07-08 | Malfunction | None | Device Displays Incorrect Message |
| 2017-07-05 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-07-04 | Injury | None | Insufficient Information |
| 2017-06-27 | Malfunction | None | Electromagnetic Interference, Device Displays Incorrect Message |
| 2017-06-26 | Injury | None | Mechanical Problem, Sticking |
| 2017-06-25 | Malfunction | None | Break, Component Falling, Visual Prompts will not Clear, Device Displays Incorrect Message |
| 2017-06-20 | Injury | None | No Display/Image |
| 2017-06-16 | Malfunction | None | Device Displays Incorrect Message |
| 2017-06-15 | Malfunction | None | Break, Detachment Of Device Component, Component Missing |
| 2017-06-13 | Injury | None | Insufficient Information |
| 2017-06-12 | Injury | None | Insufficient Information |
| 2017-06-12 | Malfunction | None | Failure to Deliver |
| 2017-06-12 | Injury | None | Bent, Noise, Audible |
| 2017-06-08 | Injury | None | Occlusion Within Device, Device Displays Incorrect Message |
| 2017-06-07 | Malfunction | None | Break, Unable to Obtain Readings |
| 2017-06-07 | Malfunction | None | Break |
| 2017-06-06 | Malfunction | None | No Display/Image, Device Displays Incorrect Message |
| 2017-06-04 | Malfunction | None | Appropriate Term/Code Not Available |
| 2017-06-03 | Malfunction | None | Device Displays Incorrect Message |
| 2017-06-02 | Malfunction | None | Premature Discharge of Battery, No Display/Image |
| 2017-06-01 | Malfunction | None | Break |
| 2017-05-29 | Injury | None | Defective Component, Invalid Sensing, Device Displays Incorrect Message |
| 2017-05-26 | Malfunction | None | Device Displays Incorrect Message |
| 2017-05-25 | Injury | None | Sticking |
| 2017-05-20 | Injury | None | Device Operates Differently Than Expected |
| 2017-05-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-14 | Injury | None | Insufficient Information |
| 2017-05-12 | Injury | None | Bent |
| 2017-05-11 | Injury | None | Difficult to Remove |
| 2017-05-10 | Injury | None | Material Discolored |
| 2017-05-10 | Injury | None | Insufficient Information |
| 2017-05-09 | Injury | None | Failure to Deliver, Device Displays Incorrect Message |
| 2017-05-07 | Malfunction | None | Application Interface Becomes Non-Functional Or Program Exits Abnormally, No Display/Image, Failure to Read Input Signal |
| 2017-05-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-01 | Injury | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-05-01 | Injury | None | Air Leak |
| 2017-04-30 | Injury | None | Device Displays Incorrect Message |
| 2017-04-30 | Injury | None | Air Leak |
| 2017-04-28 | Injury | None | Device Alarm System |
| 2017-04-28 | Injury | None | Bent |
| 2017-04-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-26 | Injury | None | Device Displays Incorrect Message |
| 2017-04-22 | Malfunction | None | No Display/Image |
| 2017-04-17 | Injury | None | Improper or Incorrect Procedure or Method |
| 2017-04-15 | Malfunction | None | No Display/Image |
| 2017-04-15 | Injury | None | Device Displays Incorrect Message |
| 2017-04-14 | Injury | None | Device Displays Incorrect Message |
| 2017-04-14 | Malfunction | None | No Display/Image, Device Displays Incorrect Message, Inappropriate or Unexpected Reset |
| 2017-04-13 | Malfunction | None | Break, Improper or Incorrect Procedure or Method |
| 2017-04-12 | Injury | None | No Display/Image, Device Displays Incorrect Message |
| 2017-04-11 | Malfunction | None | Connection Problem, Device Operates Differently Than Expected |
| 2017-04-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-10 | Injury | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-04-08 | Injury | None | Insufficient Information |
| 2017-04-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-04 | Injury | None | Device Displays Incorrect Message |
| 2017-04-03 | Malfunction | None | Device Displays Incorrect Message |
| 2017-04-03 | Malfunction | None | Device Displays Incorrect Message |
| 2017-04-02 | Malfunction | None | Crack, Poor Quality Image, Scratched Material |
| 2017-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-30 | Injury | None | Improper or Incorrect Procedure or Method |
| 2017-03-29 | Injury | None | Insufficient Information |
| 2017-03-28 | Injury | None | Bent, Use of Incorrect Control/Treatment Settings, Kinked |
| 2017-03-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-21 | Injury | None | High Test Results |
| 2017-03-21 | Malfunction | None | Difficult to Remove |
| 2017-03-17 | Malfunction | None | No Display/Image |
| 2017-03-15 | Malfunction | None | Device Displays Incorrect Message, Inappropriate or Unexpected Reset |
| 2017-03-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-06 | Injury | None | Break |
| 2017-02-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-24 | Injury | None | No Display/Image, Device Operates Differently Than Expected |
| 2017-02-24 | Malfunction | None | No Display/Image |
| 2017-02-22 | Injury | None | Incorrect Or Inadequate Test Results |
| 2017-02-20 | Injury | None | Device Operates Differently Than Expected |
| 2017-02-20 | Injury | None | Device Operates Differently Than Expected |
| 2017-02-18 | Malfunction | None | No Display/Image |
| 2017-02-15 | Injury | None | Use of Incorrect Control/Treatment Settings |
| 2017-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-14 | Malfunction | None | No Display/Image |
| 2017-02-09 | Malfunction | None | Break |
| 2017-02-03 | Injury | None | Calibration Problem |
| 2017-02-02 | Malfunction | None | Device Displays Incorrect Message |
| 2017-01-31 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-01-28 | Malfunction | None | No Display/Image |
| 2017-01-27 | Malfunction | None | Leak/Splash, Device Displays Incorrect Message, Material Protrusion/Extrusion |
| 2017-01-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-22 | Injury | None | Low Test Results |
| 2017-01-22 | Injury | None | Device Displays Incorrect Message |
| 2017-01-19 | Injury | None | Incorrect Or Inadequate Test Results |
| 2017-01-13 | Injury | None | Device Displays Incorrect Message |
| 2017-01-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-09 | Injury | None | Device Operates Differently Than Expected |
| 2017-01-09 | Injury | None | Bent |
| 2017-01-09 | Injury | None | Bent, Device Displays Incorrect Message |
| 2017-01-07 | Injury | None | Device Operates Differently Than Expected |
| 2017-01-05 | Injury | None | Device Displays Incorrect Message |
| 2017-01-04 | Injury | None | Failure to Deliver |
| 2017-01-02 | Injury | None | Bent |
| 2017-01-02 | Malfunction | None | Poor Quality Image |
| 2016-12-26 | Injury | None | Excess Flow or Over-Infusion |
| 2016-12-20 | Injury | None | Air Leak |
| 2016-12-19 | Injury | None | Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected |
| 2016-12-18 | Injury | None | Sticking |
| 2016-12-16 | Injury | None | Incorrect Or Inadequate Test Results |
| 2016-12-15 | Injury | None | Insufficient Information |
| 2016-12-15 | Injury | None | Device Inoperable |
| 2016-12-15 | Malfunction | None | Device Displays Incorrect Message, Battery Problem |
| 2016-12-12 | Injury | None | Insufficient Information |
| 2016-12-12 | Injury | None | Component Falling |
| 2016-12-12 | Injury | None | Device Operates Differently Than Expected |
| 2016-12-12 | Injury | None | High Test Results, Battery Problem |
| 2016-12-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-08 | Injury | None | Bent |
| 2016-12-08 | Malfunction | None | No Display/Image |
| 2016-12-06 | Injury | None | Failure to Deliver |
| 2016-12-05 | Injury | None | Device Operates Differently Than Expected |
| 2016-12-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-02 | Injury | None | Bent |
| 2016-11-28 | Injury | None | Device Displays Incorrect Message |
| 2016-11-28 | Malfunction | None | Break, Difficult or Delayed Activation, Device Displays Incorrect Message |
| 2016-11-26 | Injury | None | Failure of Device to Self-Test, Pressure Problem |
| 2016-11-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-11-23 | Injury | None | Insufficient Information |
| 2016-11-23 | Injury | None | Sticking, Improper Device Output |
| 2016-11-23 | Injury | None | Device Operates Differently Than Expected |
| 2016-11-21 | Malfunction | None | Device Displays Incorrect Message |
| 2016-11-20 | Malfunction | None | Device Displays Incorrect Message |
| 2016-11-18 | Malfunction | None | Device Stops Intermittently |
| 2016-11-08 | Injury | None | Device Displays Incorrect Message |
| 2016-11-06 | Injury | None | Device Displays Incorrect Message |
| 2016-11-04 | Injury | None | Device Displays Incorrect Message |
| 2016-10-31 | Injury | None | Bent |
| 2016-10-31 | Injury | None | Device Displays Incorrect Message, Device Sensing Problem |
| 2016-10-27 | Injury | None | Failure to Prime |
| 2016-10-24 | Injury | None | Failure to Deliver |
| 2016-10-24 | Injury | None | Therapeutic or Diagnostic Output Failure |
| 2016-10-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-22 | Injury | None | Bent |
| 2016-10-22 | Malfunction | None | No Display/Image |
| 2016-10-21 | Malfunction | None | No Display/Image |
| 2016-10-19 | Injury | None | Break |
| 2016-10-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-15 | Injury | None | Insufficient Information |
| 2016-10-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-04 | Injury | None | No Display/Image |
| 2016-10-04 | Injury | None | Device Operates Differently Than Expected |
| 2016-10-03 | Injury | None | Device Operates Differently Than Expected |
| 2016-10-01 | Injury | None | Device Alarm System, Application Interface Becomes Non-Functional Or Program Exits Abnormally |
| 2016-09-30 | Injury | None | Bent |
| 2016-09-28 | Injury | None | Device Operates Differently Than Expected |
| 2016-09-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-27 | Malfunction | None | Device Displays Incorrect Message, Programming Issue |
| 2016-09-27 | Injury | None | Detachment of Device or Device Component |
| 2016-09-26 | Injury | None | Device Displays Incorrect Message |
| 2016-09-24 | Injury | None | Bent |
| 2016-09-18 | Injury | None | False Reading From Device Non-Compliance |
| 2016-09-16 | Injury | None | Failure to Deliver, High Test Results |
| 2016-09-15 | Malfunction | None | Device Displays Incorrect Message |
| 2016-09-11 | Injury | None | Insufficient Information |
| 2016-09-10 | Malfunction | None | Material Protrusion/Extrusion |
| 2016-09-09 | Malfunction | None | Device Displays Incorrect Message |
| 2016-09-09 | Malfunction | None | No Display/Image |
| 2016-09-09 | Malfunction | None | Break, Component Missing |
| 2016-09-07 | Injury | None | Insufficient Information |
| 2016-09-07 | Injury | None | Insufficient Information |
| 2016-09-07 | Injury | None | Insufficient Information |
| 2016-09-06 | Injury | None | Device Displays Incorrect Message |
| 2016-09-04 | Injury | None | Inaccurate Delivery |
| 2016-09-03 | Injury | None | Bent |
| 2016-09-02 | Malfunction | None | Device Displays Incorrect Message, Data Back-Up Problem, Device Operates Differently Than Expected |
| 2016-09-01 | Injury | None | Device Operates Differently Than Expected |
| 2016-09-01 | Injury | None | Device Displays Incorrect Message |
| 2016-08-29 | Injury | None | Device Displays Incorrect Message |
| 2016-08-27 | Injury | None | Device Displays Incorrect Message |
| 2016-08-21 | Injury | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2016-08-21 | Injury | None | Insufficient Information |
| 2016-08-20 | Malfunction | None | Device Displays Incorrect Message, Electromagnetic Compatibility Problem |
| 2016-08-19 | Injury | None | Device Displays Incorrect Message, Calibration Problem, Device Operates Differently Than Expected |
| 2016-08-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-17 | Injury | None | Difficult or Delayed Activation |
| 2016-08-15 | Injury | None | Improper or Incorrect Procedure or Method |
| 2016-08-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-12 | Injury | None | Device Slipped |
| 2016-08-11 | Injury | None | Device Displays Incorrect Message |
| 2016-08-06 | Injury | None | Failure to Deliver |
| 2016-08-06 | Injury | None | Air Leak |
| 2016-08-04 | Malfunction | None | Device Displays Incorrect Message |
| 2016-08-04 | Injury | None | Device Operates Differently Than Expected |
| 2016-08-01 | Injury | None | Insufficient Information |
| 2016-07-30 | Injury | None | Bent |
| 2016-07-30 | Injury | None | Bent |
| 2016-07-24 | Injury | None | Insufficient Information |
| 2016-07-23 | Malfunction | None | No Display/Image |
| 2016-07-21 | Injury | None | Insufficient Information |
| 2016-07-20 | Malfunction | None | Failure to Prime |
| 2016-07-20 | Injury | None | Device Emits Odor, Sticking, High Test Results, Moisture or Humidity Problem |
| 2016-07-18 | Injury | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2016-07-16 | Malfunction | None | No Display/Image, Device Inoperable |
| 2016-07-16 | Malfunction | None | No Display/Image, Device Inoperable |
| 2016-07-16 | Injury | None | Device Slipped |
| 2016-07-16 | Injury | None | Bent |
| 2016-07-16 | Injury | None | Retraction Problem, Battery Problem |
| 2016-07-10 | Malfunction | None | Device Inoperable, Device Displays Incorrect Message |
| 2016-07-05 | Injury | None | Air Leak |
| 2016-07-02 | Malfunction | None | Moisture or Humidity Problem, Noise, Audible |
| 2016-07-02 | Malfunction | None | No Display/Image |
| 2016-05-30 | Injury | None | Air Leak |
| 2016-05-12 | Injury | None | Device Displays Incorrect Message |
| 2016-03-31 | Injury | None | Failure to Deliver, Device Displays Incorrect Message |
| 2015-08-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-07-13 | Malfunction | None | Device Inoperable |
| 2014-07-13 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-12 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-12 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2014-07-11 | Injury | None | Insufficient Information |
| 2014-07-10 | Injury | None | Improper or Incorrect Procedure or Method |
| 2014-07-10 | Malfunction | None | Bent, Occlusion Within Device |
| 2014-07-10 | Malfunction | None | False Reading From Device Non-Compliance |
| 2014-07-10 | Injury | None | Air Leak |
| 2014-07-10 | Malfunction | None | Insufficient Information |
| 2014-07-09 | Injury | None | Insufficient Information |
| 2014-07-09 | Malfunction | None | Loss of Power, Failure to Power Up, Device Displays Incorrect Message, Battery Problem |
| 2014-07-09 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-09 | Malfunction | None | Device Slipped |
| 2014-07-09 | Death | None | Insufficient Information |
| 2014-07-08 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-08 | Malfunction | None | Device Displays Incorrect Message, Communication or Transmission Problem |
| 2014-07-08 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-08 | Malfunction | None | False Reading From Device Non-Compliance, Inaccurate Delivery, Naturally Worn |
| 2014-07-08 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-08 | Malfunction | None | Failure to Read Input Signal, Low Test Results |
| 2014-07-07 | Malfunction | None | Incorrect Or Inadequate Test Results, Device Displays Incorrect Message |
| 2014-07-07 | Malfunction | None | Device Alarm System |
| 2014-07-07 | Malfunction | None | Failure to Deliver, Device Displays Incorrect Message |
| 2014-07-07 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-07 | Malfunction | None | Incorrect Or Inadequate Test Results, Difficult or Delayed Activation, Device Operates Differently Than Expected |
| 2014-07-07 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-07 | Malfunction | None | Device Alarm System, Device Operates Differently Than Expected |
| 2014-07-07 | Malfunction | None | Improper or Incorrect Procedure or Method, Device Displays Incorrect Message |
| 2014-07-07 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-06 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2014-07-06 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-05 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-05 | Malfunction | None | Component Falling, No Display/Image, Improper or Incorrect Procedure or Method, Scratched Material |
| 2014-07-05 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-05 | Unknown | None | No Display/Image, Use of Device Problem |
| 2014-07-05 | Injury | None | Failure to Deliver |
| 2014-07-04 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-03 | Injury | None | Device Alarm System, Device Sensing Problem |
| 2014-07-03 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-07-03 | Malfunction | None | No Display/Image, Loss of Power |
| 2014-07-03 | Malfunction | None | Incorrect Or Inadequate Test Results |
| 2014-07-02 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-02 | Malfunction | None | Failure to Deliver |
| 2014-07-02 | Malfunction | None | Melted, Overheating of Device |
| 2014-07-02 | Malfunction | None | Bent, Device Displays Incorrect Message |
| 2014-07-02 | Malfunction | None | Improper or Incorrect Procedure or Method, Device Displays Incorrect Message |
| 2014-07-01 | Injury | None | Failure to Deliver, Device Displays Incorrect Message |
| 2014-07-01 | Malfunction | None | Calibration Error, Incorrect Or Inadequate Test Results |
| 2014-07-01 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-01 | Malfunction | None | Failure to Deliver, High Test Results |
| 2014-07-01 | Malfunction | None | Device Displays Incorrect Message |
| 2014-07-01 | Malfunction | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2014-07-01 | Malfunction | None | High Test Results |
| 2014-07-01 | Injury | None | Insufficient Information |
| 2014-07-01 | Injury | None | Bent, Failure to Deliver |
| 2014-06-30 | Malfunction | None | Component Missing, Failure to Deliver |
| 2014-06-29 | Malfunction | None | Bent, False Reading From Device Non-Compliance, Device Contamination with Body Fluid |
| 2014-06-29 | Injury | None | Failure to Deliver |
| 2014-06-28 | Injury | None | Insufficient Information |
| 2014-06-28 | Injury | None | Bent |
| 2014-06-27 | Malfunction | None | Application Interface Becomes Non-Functional Or Program Exits Abnormally, Device Inoperable |
| 2014-06-27 | Injury | None | Complete Blockage |
| 2014-06-27 | Malfunction | None | Device Displays Incorrect Message |
| 2014-06-26 | Malfunction | None | Device Displays Incorrect Message, Scratched Material |
| 2014-06-26 | Injury | None | Insufficient Information |
| 2014-06-26 | Malfunction | None | Device Displays Incorrect Message |
| 2014-06-25 | Malfunction | None | Failure to Deliver |
| 2014-06-25 | Injury | None | Insufficient Information |
| 2014-06-23 | Injury | None | Bent, Device Displays Incorrect Message |
| 2014-06-21 | Malfunction | None | Device Displays Incorrect Message, Communication or Transmission Problem |
| 2014-06-21 | Malfunction | None | Failure to Deliver, Device Displays Incorrect Message |
| 2014-06-21 | Malfunction | None | Communication or Transmission Problem |
| 2014-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-06-20 | Malfunction | None | Calibration Error, Device Displays Incorrect Message |
| 2014-06-20 | Malfunction | None | Device Displays Incorrect Message |
| 2014-06-20 | Malfunction | None | False Reading From Device Non-Compliance, Device Displays Incorrect Message, Communication or Transmission Problem |
| 2014-06-20 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2014-06-20 | Malfunction | None | Device Displays Incorrect Message |
| 2014-06-20 | Malfunction | None | Improper or Incorrect Procedure or Method, Device Displays Incorrect Message |
| 2014-06-20 | Malfunction | None | No Display/Image, Device Displays Incorrect Message |
| 2014-06-20 | Injury | None | Insufficient Information |
| 2014-06-19 | Malfunction | None | Detachment of Device or Device Component |
| 2014-06-18 | Malfunction | None | Calibration Error, Kinked, Incorrect Or Inadequate Test Results |
| 2014-06-18 | Malfunction | None | Device Displays Incorrect Message |
| 2014-06-18 | Malfunction | None | No Display/Image, Device Displays Incorrect Message |
| 2014-06-18 | Malfunction | None | Communication or Transmission Problem |
| 2014-06-18 | Malfunction | None | Calibration Problem |
| 2014-06-18 | Malfunction | None | Device Displays Incorrect Message, Communication or Transmission Problem |
| 2014-06-18 | Malfunction | None | Device Displays Incorrect Message, Calibration Problem |
| 2014-06-17 | Malfunction | None | Failure to Prime, Difficult to Remove, Retraction Problem, Device Displays Incorrect Message, Connection Problem |
| 2014-06-17 | Malfunction | None | Device Displays Incorrect Message |
| 2014-06-17 | Malfunction | None | Device Inoperable |
| 2014-06-17 | Malfunction | None | Device Displays Incorrect Message |
| 2014-06-16 | Injury | None | Insufficient Information |
| 2014-06-16 | Malfunction | None | Insufficient Information |
| 2014-06-15 | Malfunction | None | Device Displays Incorrect Message |
| 2014-06-15 | Malfunction | None | Improper Device Output |
| 2014-06-15 | Malfunction | None | Device Displays Incorrect Message, Device Sensing Problem |
| 2014-06-15 | Malfunction | None | Device Displays Incorrect Message |
| 2014-06-15 | Malfunction | None | Fluid/Blood Leak, Device Displays Incorrect Message |
| 2014-06-15 | Malfunction | None | Moisture Damage |
| 2014-06-13 | Death | None | Insufficient Information |
| 2014-06-12 | Malfunction | None | Device Displays Incorrect Message |
| 2014-06-10 | Malfunction | None | No Display/Image |
| 2014-06-09 | Malfunction | None | Failure to Deliver |
| 2014-06-06 | Injury | None | Improper or Incorrect Procedure or Method |
| 2014-06-03 | Malfunction | None | Device Displays Incorrect Message |
| 2014-05-29 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-05-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2014-05-24 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2014-05-18 | Malfunction | None | Calibration Error, Kinked |
| 2014-05-13 | Malfunction | None | Device Displays Incorrect Message |
| 2014-05-13 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-05-04 | Malfunction | None | Failure to Deliver |
| 2014-05-01 | Injury | None | Insufficient Information |
| 2014-04-29 | Malfunction | None | Device Displays Incorrect Message |
| 2014-04-28 | Malfunction | None | Device Displays Incorrect Message |
| 2014-04-28 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-04-26 | Injury | None | Device Operates Differently Than Expected |
| 2014-04-22 | Malfunction | None | Device Displays Incorrect Message |
| 2014-04-22 | Malfunction | None | Leak/Splash, Battery Problem |
| 2014-04-21 | Malfunction | None | Device Displays Incorrect Message |
| 2014-04-18 | Malfunction | None | Device Displays Incorrect Message |
| 2014-04-15 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-04-13 | Malfunction | None | Device Displays Incorrect Message |
| 2014-04-09 | Malfunction | None | Device Displays Incorrect Message |
| 2014-04-07 | Malfunction | None | Device Displays Incorrect Message |
| 2014-04-06 | Injury | None | Insufficient Information |
| 2014-04-05 | Malfunction | None | Device Displays Incorrect Message |
| 2014-03-24 | Malfunction | None | Device Displays Incorrect Message |
| 2014-03-23 | Malfunction | None | Device Displays Incorrect Message |
| 2014-03-20 | Malfunction | None | Device Displays Incorrect Message |
| 2014-03-18 | Malfunction | None | Device Displays Incorrect Message |
| 2014-03-18 | Malfunction | None | Device Displays Incorrect Message |
| 2014-03-12 | Malfunction | None | Device Displays Incorrect Message |
| 2014-03-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-03-10 | Malfunction | None | No Display/Image |
| 2014-03-10 | Malfunction | None | Moisture Damage |
| 2014-03-07 | Malfunction | None | No Display/Image, Device Displays Incorrect Message |
| 2014-03-04 | Malfunction | None | Device Displays Incorrect Message |
| 2014-02-28 | Malfunction | None | Device Displays Incorrect Message |
| 2014-02-25 | Malfunction | None | Failure to Deliver |
| 2014-02-24 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-02-19 | Malfunction | None | Device Inoperable |
| 2014-02-19 | Malfunction | None | Device Displays Incorrect Message |
| 2014-02-13 | Malfunction | None | Device Displays Incorrect Message |
| 2014-02-11 | Malfunction | None | Device Displays Incorrect Message |
| 2014-02-05 | Malfunction | None | No Display/Image, Device Displays Incorrect Message |
| 2014-01-21 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2014-01-20 | Malfunction | None | Device Displays Incorrect Message |
| 2014-01-20 | Malfunction | None | Device Displays Incorrect Message |
| 2014-01-20 | Malfunction | None | Device Displays Incorrect Message |
| 2014-01-19 | Malfunction | None | No Display/Image, Visual Prompts will not Clear, Noise, Audible |
| 2014-01-19 | Malfunction | None | No Display/Image |
| 2014-01-15 | Malfunction | None | Air Leak |
| 2014-01-14 | Malfunction | None | Device Inoperable, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2014-01-09 | Malfunction | None | Device Displays Incorrect Message |
| 2014-01-09 | Malfunction | None | Bent, Device Displays Incorrect Message |
| 2014-01-06 | Malfunction | None | Device Displays Incorrect Message |
| 2014-01-05 | Malfunction | None | Device Inoperable |
| 2014-01-03 | Malfunction | None | Device Displays Incorrect Message |
| 2013-12-27 | Malfunction | None | Device Displays Incorrect Message |
| 2013-12-15 | Malfunction | None | Device Displays Incorrect Message |
| 2013-12-12 | Malfunction | None | Air Leak |
| 2013-12-03 | Malfunction | None | Device Displays Incorrect Message |
| 2013-12-03 | Malfunction | None | Incorrect Or Inadequate Test Results, Device Displays Incorrect Message |
| 2013-11-16 | Malfunction | None | Device Displays Incorrect Message |
| 2013-10-25 | Malfunction | None | Device Displays Incorrect Message |
| 2013-01-05 | Malfunction | None | Device Operates Differently Than Expected |