FREESTYLE LIBRE Adverse Event — Malfunction (MDR 2954323-2020-02990)
FREESTYLE LIBRE Adverse Event — Malfunction (MDR 2954323-2020-02990) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FREESTYLE LIBRE; Generic name: FLASH GLUCOSE MONITORING SYSTEM; Manufacturer: ABBOTT DIABETES CARE INC.
| Device | FREESTYLE LIBRE |
|---|---|
| Generic name | FLASH GLUCOSE MONITORING SYSTEM |
| Manufacturer | ABBOTT DIABETES CARE INC |
| Report number | 2954323-2020-02990 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | SENSOR (0M0063M9Y7W) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SENSOR AND NO ISSUE WAS OBSERVED. SENSOR PLUG WAS RETURNED AND WAS FULLY SEATED. EXTRACTED DATA USING APPROVED SOFTWARE, SENSOR WAS FOUND TO BE IN SENSOR STATE IS 5 (INDICATING NORMAL TERMINATION). REMOVED PLUG AND INSPECTED PLUG ASSEMBLY, UNCURLED SIDE SNAP WAS OBSERVED, INDICATING IMPROPER AS |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →