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:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2023 | Premature Discharge of Battery | 1 | Device |
| 2023 | Power Problem | 1 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2022 | Power Problem | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Battery Problem | 1 | Device |
| 2021 | Hypoglycemia | 1 | Patient |
| 2021 | Hyperglycemia | 1 | Patient |
| 2021 | Computer Software Problem | 1 | Device |
| 2021 | Break | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Wireless Communication Problem | 1 | Device |
| 2019 | Visual Prompts will not Clear | 1 | Device |
| 2019 | Use of Device Problem | 1 | Device |
| 2019 | Priming Problem | 13 | Device |
| 2019 | Premature Discharge of Battery | 4 | Device |
| 2019 | Power Problem | 28 | Device |
| 2019 | Patient Device Interaction Problem | 36 | Device |
| 2019 | Obstruction of Flow | 41 | Device |
| 2019 | No Display/Image | 6 | Device |
| 2019 | No Apparent Adverse Event | 16 | Device |
| 2019 | Moisture or Humidity Problem | 4 | Device |
| 2019 | Mechanical Problem | 63 | Device |
| 2019 | Material Integrity Problem | 5 | Device |
| 2019 | Intermittent Communication Failure | 2 | Device |
| 2019 | Insufficient Information | 2 | Device |
| 2019 | Insufficient Flow or Under Infusion | 1 | Device |
| 2019 | Failure to Cycle | 5 | Device |
| 2019 | Excess Flow or Over-Infusion | 1 | Device |
| 2019 | Display or Visual Feedback Problem | 14 | Device |
| 2019 | Device Difficult to Program or Calibrate | 50 | Device |
| 2019 | Device Alarm System | 4 | Device |
| 2019 | Detachment of Device or Device Component | 6 | Device |
| 2019 | Date/Time-Related Software Problem | 1 | Device |
| 2019 | Connection Problem | 4 | Device |
| 2019 | Communication or Transmission Problem | 2 | Device |
| 2019 | Battery Problem | 23 | Device |
| 2019 | Appropriate Term/Code Not Available | 2 | Device |
| 2019 | Application Program Problem: Dose Calculation Error | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 18 | Device |
| 2018 | Visual Prompts will not Clear | 1 | Device |
| 2018 | Vibration | 1 | Device |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Unexpected Therapeutic Results | 1 | Device |
| 2018 | Sticking | 2 | Device |
| 2018 | Scratched Material | 1 | Device |
| 2018 | Priming Problem | 11 | Device |
| 2018 | Premature Discharge of Battery | 3 | Device |
| 2018 | Power Problem | 18 | Device |
| 2018 | Poor Quality Image | 1 | Device |
| 2018 | Patient Device Interaction Problem | 26 | Device |
| 2018 | Obstruction of Flow | 16 | Device |
| 2018 | Noise, Audible | 1 | Device |
| 2018 | No Flow | 2 | Device |
| 2018 | No Display/Image | 28 | Device |
| 2018 | No Apparent Adverse Event | 18 | Device |
| 2018 | Moisture or Humidity Problem | 8 | Device |
| 2018 | Moisture Damage | 1 | Device |
| 2018 | Mechanical Problem | 25 | Device |
| 2018 | Material Integrity Problem | 1 | Device |
| 2018 | Material Discolored | 1 | Device |
| 2018 | Low Battery | 1 | Device |
| 2018 | Looping | 1 | Device |
| 2018 | Insufficient Information | 7 | Device |
| 2018 | Insufficient Flow or Under Infusion | 4 | Device |
| 2018 | Incorrect Or Inadequate Test Results | 2 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2018 | Human-Device Interface Problem | 1 | Device |
| 2018 | High Test Results | 6 | Device |
| 2018 | False Reading From Device Non-Compliance | 1 | Device |
| 2018 | Failure to Power Up | 1 | Device |
| 2018 | Failure to Interrogate | 1 | Device |
| 2018 | Failure to Deliver | 10 | Device |
| 2018 | Failure to Cycle | 4 | Device |
| 2018 | Failure of Device to Self-Test | 1 | Device |
| 2018 | Display or Visual Feedback Problem | 9 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 10 | Device |
| 2018 | Device Displays Incorrect Message | 46 | Device |
| 2018 | Device Difficult to Program or Calibrate | 18 | Device |
| 2018 | Device Alarm System | 3 | Device |
| 2018 | Detachment of Device or Device Component | 5 | Device |
| 2018 | Detachment Of Device Component | 1 | Device |
| 2018 | Crack | 5 | Device |
| 2018 | Connection Problem | 2 | Device |
| 2018 | Break | 4 | Device |
| 2018 | Bent | 4 | Device |
| 2018 | Battery Problem | 4 | Device |
| 2018 | Appropriate Term/Code Not Available | 6 | Device |
| 2018 | Air Leak | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 31 | Device |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Unexpected Therapeutic Results | 1 | Device |
| 2017 | Structural Problem | 1 | Device |
| 2017 | Sticking | 2 | Device |
| 2017 | Scratched Material | 1 | Device |
| 2017 | Retraction Problem | 2 | Device |
| 2017 | Reset Problem | 1 | Device |
| 2017 | Programming Issue | 1 | Device |
| 2017 | Pressure Problem | 1 | Device |
| 2017 | Premature Discharge of Battery | 1 | Device |
| 2017 | Patient Device Interaction Problem | 2 | Device |
| 2017 | Operating System Becomes Nonfunctional | 1 | Device |
| 2017 | Nonstandard Device | 1 | Device |
| 2017 | Noise, Audible | 1 | Device |
| 2017 | No Flow | 1 | Device |
| 2017 | No Display/Image | 31 | Device |
| 2017 | No Apparent Adverse Event | 1 | Device |
| 2017 | Moisture or Humidity Problem | 1 | Device |
| 2017 | Moisture Damage | 5 | Device |
| 2017 | Material Protrusion/Extrusion | 1 | Device |
| 2017 | Low Test Results | 5 | Device |
| 2017 | Low Battery | 2 | Device |
| 2017 | Loss of Power | 4 | Device |
| 2017 | Loose or Intermittent Connection | 1 | Device |
| 2017 | Leak/Splash | 4 | Device |
| 2017 | Invalid Sensing | 2 | Device |
| 2017 | Insufficient Information | 21 | Device |
| 2017 | Insufficient Flow or Under Infusion | 1 | Device |
| 2017 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2017 | Inappropriate or Unexpected Reset | 3 | Device |
| 2017 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2017 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2017 | Improper Flow or Infusion | 1 | Device |
| 2017 | High Test Results | 4 | Device |
| 2017 | High Readings | 1 | Device |
| 2017 | Fluid/Blood Leak | 1 | Device |
| 2017 | False Reading From Device Non-Compliance | 1 | Device |
| 2017 | Failure to Sense | 1 | Device |
| 2017 | Failure to Read Input Signal | 2 | Device |
| 2017 | Failure to Prime | 3 | Device |
| 2017 | Failure to Power Up | 4 | Device |
| 2017 | Failure to Deliver | 14 | Device |
| 2017 | Failure of Device to Self-Test | 3 | Device |
| 2017 | Excess Flow or Over-Infusion | 2 | Device |
| 2017 | Electromagnetic Interference | 1 | Device |
| 2017 | Display or Visual Feedback Problem | 1 | Device |
| 2017 | Device Stops Intermittently | 2 | Device |
| 2017 | Device Slipped | 1 | Device |
| 2017 | Device Sensing Problem | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 35 | Device |
| 2017 | Device Inoperable | 13 | Device |
| 2017 | Device Displays Incorrect Message | 90 | Device |
| 2017 | Device Dislodged or Dislocated | 1 | Device |
| 2017 | Device Difficult to Program or Calibrate | 1 | Device |
| 2017 | Device Alarm System | 8 | Device |
| 2017 | Detachment Of Device Component | 2 | Device |
| 2017 | Defective Component | 2 | Device |
| 2017 | Defective Alarm | 2 | Device |
| 2017 | Date/Time-Related Software Problem | 2 | Device |
| 2017 | Crack | 13 | Device |
| 2017 | Component Missing | 3 | Device |
| 2017 | Component Falling | 3 | Device |
| 2017 | Communication or Transmission Problem | 2 | Device |
| 2017 | Break | 17 | Device |
| 2017 | Bent | 13 | Device |
| 2017 | Battery Problem | 8 | Device |
| 2017 | Appropriate Term/Code Not Available | 4 | Device |
| 2017 | Application Program Problem | 1 | Device |
| 2017 | Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 | Device |
| 2017 | Air Leak | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 28 | Device |
| 2016 | Use of Device Problem | 1 | Device |
| 2016 | Self-Activation or Keying | 1 | Device |
| 2016 | Pressure Problem | 1 | Device |
| 2016 | Poor Quality Image | 1 | Device |
| 2016 | No Display/Image | 13 | Device |
| 2016 | Material Protrusion/Extrusion | 2 | Device |
| 2016 | Material Deformation | 1 | Device |
| 2016 | Low Test Results | 1 | Device |
| 2016 | Loss of Power | 1 | Device |
| 2016 | Loose or Intermittent Connection | 1 | Device |
| 2016 | Insufficient Information | 10 | Device |
| 2016 | Insufficient Flow or Under Infusion | 1 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 1 | Device |
| 2016 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2016 | Image Display Error/Artifact | 1 | Device |
| 2016 | High Readings | 1 | Device |
| 2016 | Fluid/Blood Leak | 1 | Device |
| 2016 | Failure to Read Input Signal | 1 | Device |
| 2016 | Failure to Deliver | 11 | Device |
| 2016 | Failure To Adhere Or Bond | 2 | Device |
| 2016 | Excess Flow or Over-Infusion | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 9 | Device |
| 2016 | Device Inoperable | 2 | Device |
| 2016 | Device Displays Incorrect Message | 25 | Device |
| 2016 | Device Alarm System | 1 | Device |
| 2016 | Detachment Of Device Component | 1 | Device |
| 2016 | Crack | 1 | Device |
| 2016 | Component Falling | 1 | Device |
| 2016 | Bent | 10 | Device |
| 2016 | Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 | Device |
| 2016 | Air Leak | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
| 2015 | Failure to Transmit Record | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 3 | Device |