FLASH 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 | Polydipsia | 1 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Loss of consciousness | 3 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Hypoglycemia | 4 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Diaphoresis | 1 | Patient |
| 2024 | Convulsion/Seizure | 1 | Patient |
| 2024 | Confusion/ Disorientation | 1 | Patient |
| 2024 | Unintended Electrical Shock | 1 | Device |
| 2024 | Unable to Obtain Readings | 3 | Device |
| 2024 | Product Quality Problem | 9 | Device |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | No Device Output | 2 | Device |
| 2024 | Low Readings | 1 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 603 | Device |
| 2024 | Failure to Power Up | 2 | Device |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Shaking/Tremors | 2 | Patient |
| 2023 | Loss of consciousness | 14 | Patient |
| 2023 | Insufficient Information | 4 | Patient |
| 2023 | Hypoglycemia | 17 | Patient |
| 2023 | Hyperglycemia | 4 | Patient |
| 2023 | Fatigue | 3 | Patient |
| 2023 | Electric Shock | 1 | Patient |
| 2023 | Dizziness | 3 | Patient |
| 2023 | Diaphoresis | 3 | Patient |
| 2023 | Convulsion/Seizure | 3 | Patient |
| 2023 | Confusion/ Disorientation | 1 | Patient |
| 2023 | Burn(s) | 1 | Patient |
| 2023 | Blurred Vision | 1 | Patient |
| 2023 | Unable to Obtain Readings | 16 | Device |
| 2023 | Product Quality Problem | 119 | Device |
| 2023 | Premature Discharge of Battery | 3 | Device |
| 2023 | No Device Output | 1 | Device |
| 2023 | Low Readings | 3 | Device |
| 2023 | Key or Button Unresponsive/not Working | 1 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 1201 | Device |
| 2023 | High Readings | 5 | Device |
| 2023 | Failure to Power Up | 11 | Device |
| 2023 | Failure to Charge | 1 | Device |
| 2023 | Display or Visual Feedback Problem | 1 | Device |
| 2023 | Device Displays Incorrect Message | 9 | Device |
| 2022 | Shaking/Tremors | 1 | Patient |
| 2022 | Loss of consciousness | 3 | Patient |
| 2022 | Hypoglycemia | 3 | Patient |
| 2022 | Diaphoresis | 2 | Patient |
| 2022 | Convulsion/Seizure | 1 | Patient |
| 2022 | Unable to Obtain Readings | 14 | Device |
| 2022 | Product Quality Problem | 9 | Device |
| 2022 | Power Problem | 1 | Device |
| 2022 | No Device Output | 2 | Device |
| 2022 | Low Readings | 3 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 1633 | Device |
| 2022 | High Readings | 2 | Device |
| 2022 | Failure to Power Up | 14 | Device |
| 2022 | Erratic or Intermittent Display | 1 | Device |
| 2022 | Display or Visual Feedback Problem | 3 | Device |
| 2022 | Device Displays Incorrect Message | 5 | Device |
| 2022 | Device Alarm System | 1 | Device |
| 2022 | Detachment of Device or Device Component | 2 | Device |
| 2021 | Incorrect, Inadequate or Imprecise Result or Readings | 67 | Device |
| 2020 | Product Quality Problem | 1 | Device |