FREESTYLE LIBRE 14 DAY Adverse Event — Injury (MDR 2954323-2020-02986)
FREESTYLE LIBRE 14 DAY Adverse Event — Injury (MDR 2954323-2020-02986) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FREESTYLE LIBRE 14 DAY; Generic name: FLASH GLUCOSE MONITORING SYSTEM; Manufacturer: ABBOTT DIABETES CARE INC.
| Device | FREESTYLE LIBRE 14 DAY |
|---|---|
| Generic name | FLASH GLUCOSE MONITORING SYSTEM |
| Manufacturer | ABBOTT DIABETES CARE INC |
| Report number | 2954323-2020-02986 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND LIBRE SENSOR KITS WERE REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND LIBRE SENSOR KITS PASSED ALL TESTS PRIOR TO RELE |
| Source | openFDA MAUDE (device adverse events) |
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