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 | Shaking/Tremors | 2 | Patient |
| 2024 | Loss of consciousness | 2 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Hypoglycemia | 4 | Patient |
| 2024 | Hyperglycemia | 2 | Patient |
| 2024 | Headache | 1 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Unintended Electrical Shock | 1 | Device |
| 2024 | Unable to Obtain Readings | 2 | Device |
| 2024 | Self-Activation or Keying | 1 | Device |
| 2024 | Product Quality Problem | 1 | Device |
| 2024 | Power Problem | 1 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 6 | Device |
| 2024 | Image Display Error/Artifact | 1 | Device |
| 2024 | Failure to Power Up | 426 | Device |
| 2024 | Device Displays Incorrect Message | 1 | Device |
| 2024 | Break | 1 | Device |
| 2023 | Shaking/Tremors | 1 | Patient |
| 2023 | Loss of consciousness | 5 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hypoglycemia | 10 | Patient |
| 2023 | Hyperglycemia | 1 | Patient |
| 2023 | Headache | 1 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2023 | Dizziness | 3 | Patient |
| 2023 | Convulsion/Seizure | 3 | Patient |
| 2023 | Blurred Vision | 2 | Patient |
| 2023 | Unable to Obtain Readings | 6 | Device |
| 2023 | Product Quality Problem | 2 | Device |
| 2023 | No Device Output | 1 | Device |
| 2023 | Low Readings | 4 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 15 | Device |
| 2023 | Failure to Power Up | 633 | Device |
| 2023 | Device Displays Incorrect Message | 3 | Device |
| 2022 | Polydipsia | 3 | Patient |
| 2022 | Loss of consciousness | 4 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Hypoglycemia | 3 | Patient |
| 2022 | Hyperglycemia | 1 | Patient |
| 2022 | Dizziness | 2 | Patient |
| 2022 | Discomfort | 2 | Patient |
| 2022 | Convulsion/Seizure | 1 | Patient |
| 2022 | Unable to Obtain Readings | 9 | Device |
| 2022 | Product Quality Problem | 2 | Device |
| 2022 | Power Problem | 2 | Device |
| 2022 | No Device Output | 8 | Device |
| 2022 | Low Readings | 2 | Device |
| 2022 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 9 | Device |
| 2022 | Failure to Power Up | 405 | Device |
| 2022 | Display or Visual Feedback Problem | 1 | Device |
| 2022 | Device Displays Incorrect Message | 4 | Device |
| 2022 | Device Damaged Prior to Use | 1 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Computer Software Problem | 1 | Device |
| 2021 | High Readings | 1 | Device |