MEDISENSE OPTIUM Adverse Event — Malfunction (MDR 2954323-2008-00811)
MEDISENSE OPTIUM Adverse Event — Malfunction (MDR 2954323-2008-00811) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MEDISENSE OPTIUM; Generic name: BLOOD GLUCOSE METER; Manufacturer: ABBOTT DIABETES CARE LIMITED UK.
| Device | MEDISENSE OPTIUM |
|---|---|
| Generic name | BLOOD GLUCOSE METER |
| Manufacturer | ABBOTT DIABETES CARE LIMITED UK |
| Report number | 2954323-2008-00811 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-14 |
| Report source | Consumer |
| Narrative | CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR MEDISENSE OPTIUM METER. CUSTOMER REPORTED RECEIVING READINGS OF 107 MG/DL AND 437 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONES SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASS |
| Source | openFDA MAUDE (device adverse events) |
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