MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-01 for CHOICE A1C TEST * manufactured by Bristol-myers Squibb Company.
[16404620]
Ad for choice a1c test said that a! % reduction in a1c lowers the risk of eye, kidney, and nerve damage by 37%. Rptr believes it should say a one percentage point reduction would have this impact. The ad copy is erroneous.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034804 |
| MDR Report Key | 578968 |
| Date Received | 2005-03-01 |
| Date of Report | 2005-03-01 |
| Date Added to Maude | 2005-03-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHOICE A1C TEST |
| Generic Name | HOME HGB A1C TEST MACHINE |
| Product Code | KQE |
| Date Received | 2005-03-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 568817 |
| Manufacturer | BRISTOL-MYERS SQUIBB COMPANY |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-01 |