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 |