FREESTYLE LIBRE 14 DAY Adverse Event — Injury (MDR 2954323-2020-02944)
FREESTYLE LIBRE 14 DAY Adverse Event — Injury (MDR 2954323-2020-02944) 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 | 2954323-2020-02944 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | CONSUMER |
| Narrative | NO PRODUCT HAS BEEN RETURNED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS FOR THE FS LIBRE SENSOR AND FS LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FS LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED |
| Source | openFDA MAUDE (device adverse events) |
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