BLOOD GLUCOSE SYSTEM
This device is manufactured by NIPRO DIAGNOSTICS, TRIVIDIA HEALTH.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2023 | No Apparent Adverse Event | 1 | Device |
| 2022 | Paralysis | 1 | Patient |
| 2022 | Fall | 1 | Patient |
| 2022 | Blurred Vision | 1 | Patient |
| 2022 | Physical Resistance/Sticking | 1 | Device |
| 2022 | High Test Results | 1 | Device |
| 2019 | Unable to Obtain Readings | 8 | Device |
| 2019 | Low Test Results | 12 | Device |
| 2019 | Incorrect, Inadequate or Imprecise Result or Readings | 38 | Device |
| 2019 | Incomplete or Missing Packaging | 1 | Device |
| 2019 | High Test Results | 48 | Device |
| 2019 | Device Displays Incorrect Message | 1 | Device |
| 2019 | Battery Problem | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2018 | Unable to Obtain Readings | 4 | Device |
| 2018 | Low Test Results | 12 | Device |
| 2018 | Insufficient Information | 1 | Device |
| 2018 | Incorrect, Inadequate or Imprecise Result or Readings | 3 | Device |
| 2018 | Incorrect Or Inadequate Test Results | 7 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2018 | Image Display Error/Artifact | 2 | Device |
| 2018 | High Test Results | 83 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Device Displays Incorrect Message | 7 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2017 | Low Test Results | 31 | Device |
| 2017 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2017 | Incorrect Or Inadequate Test Results | 11 | Device |
| 2017 | Image Display Error/Artifact | 4 | Device |
| 2017 | High Test Results | 122 | Device |
| 2017 | Device Displays Incorrect Message | 30 | Device |
| 2017 | Battery Problem | 7 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2016 | Low Test Results | 21 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 8 | Device |
| 2016 | Inadequate Storage | 1 | Device |
| 2016 | High Test Results | 100 | Device |
| 2016 | Device Operates Differently Than Expected | 3 | Device |
| 2016 | Device Displays Incorrect Message | 6 | Device |
| 2016 | Battery Problem | 2 | Device |
| 2015 | No Display/Image | 1 | Device |
| 2015 | Low Test Results | 32 | Device |
| 2015 | Incorrect Or Inadequate Test Results | 13 | Device |
| 2015 | Image Display Error/Artifact | 2 | Device |
| 2015 | High Test Results | 61 | Device |
| 2015 | Device Displays Incorrect Message | 4 | Device |
| 2015 | Component Missing | 1 | Device |
| 2014 | Low Test Results | 9 | Device |
| 2014 | Incorrect, Inadequate or Imprecise Result or Readings | 8 | Device |
| 2014 | Incorrect Or Inadequate Test Results | 8 | Device |
| 2014 | Image Display Error/Artifact | 7 | Device |
| 2014 | High Test Results | 25 | Device |
| 2013 | Low Test Results | 2 | Device |
| 2013 | Incorrect Or Inadequate Test Results | 5 | Device |
| 2013 | Image Display Error/Artifact | 1 | Device |
| 2013 | High Test Results | 14 | Device |
| 2013 | Device Displays Incorrect Message | 1 | Device |
| 2008 | No Device Output | 1 | Device |