FREESTYLE LIBRE 14 DAY Adverse Event — Injury (MDR 2954323-2020-02945)
FREESTYLE LIBRE 14 DAY Adverse Event — Injury (MDR 2954323-2020-02945) 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 | 2954323-2020-02945 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | CONSUMER |
| Narrative | AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR LIBRE SENS |
| Source | openFDA MAUDE (device adverse events) |
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