FREESTYLE FREEDOM LITE Adverse Event — Malfunction (MDR 2954323-2020-02981)
FREESTYLE FREEDOM LITE Adverse Event — Malfunction (MDR 2954323-2020-02981) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FREESTYLE FREEDOM LITE; Generic name: BLOOD GLUCOSE MONITORING SYSTEM; Manufacturer: ABBOTT DIABETES CARE INC.
| Device | FREESTYLE FREEDOM LITE |
|---|---|
| Generic name | BLOOD GLUCOSE MONITORING SYSTEM |
| Manufacturer | ABBOTT DIABETES CARE INC |
| Report number | 2954323-2020-02981 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | TO DATE, PRODUCT HAS NOT BEEN RETURNED FOR FURTHER INVESTIGATION. THE USEFUL LIFE OF FREESTYLE FREEDOM LITE METER IS 5 YEARS. AS THE MANUFACTURING DATE OF THIS PRODUCT IS 2010, IT HAS BEEN IN DISTRIBUTION BEYOND ITS USEFUL LIFE AT THE TIME OF THE COMPLAINT. SINCE THE PRODUCT EXCEEDED ITS USEFUL LIFE, IT IS DETERMINED TO HAVE MET SPECIFICATION WHEN THE PRODUCT WAS RELEASED AND THROUGH ITS LIFESPAN. |
| Source | openFDA MAUDE (device adverse events) |
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