QUICKVUE AT-HOME OTC COVID-19 TEST
This device is manufactured by MEDTRONIC NAVIGATION, nan.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | No Apparent Adverse Event | 21 | Device |
| 2024 | False Positive Result | 9 | Device |
| 2024 | False Negative Result | 8 | Device |
| 2023 | Insufficient Information | 31 | Patient |
| 2023 | Non Reproducible Results | 2 | Device |
| 2023 | No Apparent Adverse Event | 238 | Device |
| 2023 | False Positive Result | 195 | Device |
| 2023 | False Negative Result | 20 | Device |
| 2023 | Expiration Date Error | 1 | Device |
| 2023 | Erratic Results | 16 | Device |
| 2023 | Device Markings/Labelling Problem | 1 | Device |
| 2022 | Insufficient Information | 5 | Patient |
| 2022 | No Apparent Adverse Event | 518 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 5 | Device |
| 2022 | False Positive Result | 391 | Device |
| 2022 | False Negative Result | 35 | Device |
| 2022 | Erratic Results | 41 | Device |
| 2021 | No Apparent Adverse Event | 39 | Device |
| 2021 | False Positive Result | 24 | Device |
| 2021 | False Negative Result | 5 | Device |
| 2021 | Erratic Results | 5 | Device |
| 2020 | No Apparent Adverse Event | 1 | Device |
| 2020 | False Negative Result | 1 | Device |