CGM
This device is manufactured by MEDTRONIC MINIMED.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Hypoglycemia | 1 | Patient |
| 2024 | Hyperglycemia | 2 | Patient |
| 2024 | Use of Device Problem | 3 | Device |
| 2024 | Unexpected Therapeutic Results | 2 | Device |
| 2024 | Packaging Problem | 1 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2024 | Delivered as Unsterile Product | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Hyperglycemia | 1 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2023 | Use of Device Problem | 3 | Device |
| 2023 | Unexpected Therapeutic Results | 1 | Device |
| 2023 | Calibration Problem | 1 | Device |
| 2022 | Unexpected Therapeutic Results | 2 | Device |
| 2022 | Physical Resistance/Sticking | 2 | Device |
| 2019 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2019 | Defective Component | 1 | Device |
| 2018 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2018 | Incorrect Measurement | 1 | Device |
| 2018 | Fracture | 1 | Device |
| 2018 | Device Alarm System | 1 | Device |
| 2018 | Component Missing | 1 | Device |
| 2018 | Break | 1 | Device |
| 2017 | Incorrect Measurement | 1 | Device |
| 2017 | False Reading From Device Non-Compliance | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Device Displays Incorrect Message | 1 | Device |
| 2017 | Break | 1 | Device |
| 2016 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 2 | Device |
| 2016 | Detachment Of Device Component | 2 | Device |
| 2016 | Connection Problem | 1 | Device |
| 2016 | Component Missing | 1 | Device |
| 2016 | Break | 1 | Device |
| 2015 | Unintended Collision | 1 | Device |
| 2015 | Low Test Results | 1 | Device |
| 2015 | Low Readings | 2 | Device |
| 2015 | Invalid Sensing | 1 | Device |
| 2015 | Incorrect, Inadequate or Imprecise Result or Readings | 7 | Device |
| 2015 | Incorrect Or Inadequate Test Results | 5 | Device |
| 2015 | False Reading From Device Non-Compliance | 3 | Device |
| 2015 | Failure To Adhere Or Bond | 4 | Device |
| 2015 | Difficult to Remove | 3 | Device |
| 2015 | Difficult to Insert | 1 | Device |
| 2015 | Device Sensing Problem | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 7 | Device |
| 2015 | Device Inoperable | 2 | Device |
| 2015 | Device Displays Incorrect Message | 20 | Device |
| 2015 | Device Alarm System | 1 | Device |
| 2015 | Detachment of Device or Device Component | 1 | Device |
| 2015 | Detachment Of Device Component | 1 | Device |
| 2015 | Component Missing | 1 | Device |
| 2015 | Component Falling | 1 | Device |
| 2015 | Communication or Transmission Problem | 1 | Device |
| 2015 | Calibration Problem | 1 | Device |
| 2015 | Calibration Error | 3 | Device |
| 2015 | Break | 6 | Device |
| 2015 | Bent | 5 | Device |
| 2014 | Unable to Obtain Readings | 1 | Device |
| 2014 | Sticking | 2 | Device |
| 2014 | Split | 3 | Device |
| 2014 | Shelf Life Exceeded | 1 | Device |
| 2014 | Premature End-of-Life Indicator | 1 | Device |
| 2014 | Positioning Problem | 2 | Device |
| 2014 | Mechanical Problem | 1 | Device |
| 2014 | Material Separation | 1 | Device |
| 2014 | Malposition of Device | 3 | Device |
| 2014 | Low Sensing Threshold | 1 | Device |
| 2014 | Low Readings | 2 | Device |
| 2014 | Loss of Power | 2 | Device |
| 2014 | Kinked | 1 | Device |
| 2014 | Insufficient Information | 6 | Device |
| 2014 | Incorrect, Inadequate or Imprecise Result or Readings | 9 | Device |
| 2014 | Incorrect Or Inadequate Test Results | 19 | Device |
| 2014 | Improper or Incorrect Procedure or Method | 7 | Device |
| 2014 | Improper Device Output | 1 | Device |
| 2014 | High Test Results | 2 | Device |
| 2014 | High Readings | 1 | Device |
| 2014 | Fitting Problem | 1 | Device |
| 2014 | False Reading From Device Non-Compliance | 7 | Device |
| 2014 | Failure to Sense | 3 | Device |
| 2014 | Failure to Calibrate | 1 | Device |
| 2014 | Difficult to Remove | 5 | Device |
| 2014 | Difficult to Insert | 2 | Device |
| 2014 | Device Stops Intermittently | 1 | Device |
| 2014 | Device Sensing Problem | 4 | Device |
| 2014 | Device Operates Differently Than Expected | 14 | Device |
| 2014 | Device Inoperable | 1 | Device |
| 2014 | Device Expiration Issue | 7 | Device |
| 2014 | Device Displays Incorrect Message | 43 | Device |
| 2014 | Device Contamination with Body Fluid | 1 | Device |
| 2014 | Device Alarm System | 6 | Device |
| 2014 | Detachment Of Device Component | 6 | Device |
| 2014 | Crack | 1 | Device |
| 2014 | Contamination | 1 | Device |
| 2014 | Connection Problem | 3 | Device |
| 2014 | Component Falling | 1 | Device |
| 2014 | Communication or Transmission Problem | 6 | Device |
| 2014 | Calibration Problem | 4 | Device |
| 2014 | Calibration Error | 11 | Device |
| 2014 | Break | 7 | Device |
| 2014 | Bent | 9 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2013 | Shelf Life Exceeded | 1 | Device |
| 2013 | Low Test Results | 1 | Device |
| 2013 | Insufficient Information | 4 | Device |
| 2013 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2013 | False Reading From Device Non-Compliance | 1 | Device |
| 2013 | Failure to Sense | 1 | Device |
| 2013 | Device Operates Differently Than Expected | 2 | Device |
| 2013 | Device Displays Incorrect Message | 1 | Device |
| 2013 | Device Alarm System | 1 | Device |
| 2013 | Detachment of Device or Device Component | 2 | Device |
| 2013 | Communication or Transmission Problem | 1 | Device |
| 2013 | Break | 3 | Device |
| 2012 | Patient-Device Incompatibility | 1 | Device |
| 2012 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2012 | Device Operates Differently Than Expected | 1 | Device |
| 2012 | Device Displays Incorrect Message | 1 | Device |
| 2012 | Break | 1 | Device |
| 2010 | Insufficient Information | 1 | Device |
| 2010 | Incorrect Or Inadequate Test Results | 1 | Device |