BLOOD GLUCOSE MONITORING SYSTEM
This device is manufactured by ABBOTT DIABETES CARE.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vomiting | 1 | Patient |
| 2024 | Loss of consciousness | 3 | Patient |
| 2024 | Hypoglycemia | 1 | Patient |
| 2024 | Hyperglycemia | 2 | Patient |
| 2024 | Headache | 2 | Patient |
| 2024 | Fatigue | 2 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2024 | Dizziness | 2 | Patient |
| 2024 | Decreased Appetite | 1 | Patient |
| 2024 | Convulsion/Seizure | 1 | Patient |
| 2024 | Unable to Obtain Readings | 3 | Device |
| 2024 | Power Problem | 1 | Device |
| 2024 | No Device Output | 1 | Device |
| 2024 | Low Readings | 1 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 4 | Device |
| 2024 | Failure to Power Up | 65 | Device |
| 2024 | Display or Visual Feedback Problem | 1 | Device |
| 2023 | Loss of consciousness | 5 | Patient |
| 2023 | Hypoglycemia | 5 | Patient |
| 2023 | Hyperglycemia | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Convulsion/Seizure | 2 | Patient |
| 2023 | Unable to Obtain Readings | 2 | Device |
| 2023 | Low Readings | 1 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 10 | Device |
| 2023 | High Readings | 2 | Device |
| 2023 | Failure to Power Up | 129 | Device |
| 2023 | Device Displays Incorrect Message | 1 | Device |
| 2022 | Loss of consciousness | 1 | Patient |
| 2022 | Hypoglycemia | 1 | Patient |
| 2022 | Dizziness | 1 | Patient |
| 2022 | Convulsion/Seizure | 1 | Patient |
| 2022 | Unable to Obtain Readings | 4 | Device |
| 2022 | Premature Discharge of Battery | 1 | Device |
| 2022 | No Device Output | 2 | Device |
| 2022 | Low Readings | 2 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 6 | Device |
| 2022 | Failure to Power Up | 120 | Device |
| 2022 | Device Displays Incorrect Message | 1 | Device |
| 2021 | Unable to Obtain Readings | 1 | Device |
| 2021 | Premature Discharge of Battery | 1 | Device |
| 2019 | No Display/Image | 1 | Device |
| 2019 | No Device Output | 6 | Device |
| 2019 | Low Readings | 5 | Device |
| 2019 | Incorrect, Inadequate or Imprecise Result or Readings | 18 | Device |
| 2019 | High Readings | 1 | Device |
| 2019 | Failure to Power Up | 86 | Device |
| 2019 | Device Displays Incorrect Message | 1 | Device |
| 2019 | Battery Problem | 1 | Device |
| 2018 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2018 | Failure to Power Up | 31 | Device |
| 2017 | Failure to Power Up | 39 | Device |
| 2016 | Failure to Power Up | 9 | Device |