ACCU-CHEK ® AVIVA PLUS TEST STRIPS Adverse Event — Malfunction (MDR 3011393376-2020-01559)
ACCU-CHEK ® AVIVA PLUS TEST STRIPS Adverse Event — Malfunction (MDR 3011393376-2020-01559) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACCU-CHEK ® AVIVA PLUS TEST STRIPS; Generic name: BLOOD GLUCOSE MONITORING TEST STRIPS; Manufacturer: ROCHE DIABETES CARE, INC..
| Device | ACCU-CHEK ® AVIVA PLUS TEST STRIPS |
|---|---|
| Generic name | BLOOD GLUCOSE MONITORING TEST STRIPS |
| Manufacturer | ROCHE DIABETES CARE, INC. |
| Report number | 3011393376-2020-01559 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN AVIVA METER, COMPARED TO A PROFESSIONAL METER, WITHIN 15 MINUTES: 561 MG/DL (AVIVA), 246 MG/DL (EMT'S METER), 361 MG/DL (AVIVA), AND 260 MG/DL (EMT'S METER). NO TREATMENT OR 3RD PARTY INTERVENTION WAS REQUIRED. |
| Source | openFDA MAUDE (device adverse events) |
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