MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-15 for ACCU-CHEK AVIVA PLUS 06908217001 manufactured by Roche Diabetes Care, Inc..
| Report Number | MW5091131 |
| MDR Report Key | 9335067 |
| Date Received | 2019-11-15 |
| Date of Report | 2019-11-14 |
| Date of Event | 2019-11-12 |
| Date Added to Maude | 2019-11-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACCU-CHEK AVIVA PLUS |
| Generic Name | GLUCOSE DEHYDROGENASE, GLUCOSE |
| Product Code | LFR |
| Date Received | 2019-11-15 |
| Catalog Number | 06908217001 |
| Lot Number | 498315 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIABETES CARE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-15 |