FREESTYLE LITE Adverse Event — Malfunction (MDR 2954323-2020-02952)
FREESTYLE LITE Adverse Event — Malfunction (MDR 2954323-2020-02952) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FREESTYLE LITE; Generic name: BLOOD GLUCOSE MONITORING SYSTEM; Manufacturer: ABBOTT DIABETES CARE INC.
| Device | FREESTYLE LITE |
|---|---|
| Generic name | BLOOD GLUCOSE MONITORING SYSTEM |
| Manufacturer | ABBOTT DIABETES CARE INC |
| Report number | 2954323-2020-02952 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | AN EXTENDED INVESTIGATION HAS BEEN CONDUCTED, WHICH INVOLVED A MANUFACTURING REVIEW (INCLUDING 5 YEARS OF DEVICE HISTORY RECORDS (DHRS)), PREVIOUS COMPLAINT AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATIONS CONDUCTED FOR BLANK SCREEN ISSUES, PROCESS FAILURE MODE EFFECTS ANALYSES (PFMEAS), DESIGN CONTROLS, AND DESIGN FAILURE MODE EFFECTS ANALYSES (DFMEAS), RISK MANAGEMENT REPORTS, RISK EVA |
| Source | openFDA MAUDE (device adverse events) |
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