MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-14 for HIV ANTIGEN ELISA TEST P24 933180 manufactured by Ortho Diagnostic Systems.
[26868]
Recurrent lack of performance of controls in kit for blood donor screening. No response from vendor to try to correct the problem. Blood donor testing done daily with repeated assay failures. Vendor assumes no responsibility for lack of kit performance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009097 |
| MDR Report Key | 32999 |
| Date Received | 1996-05-14 |
| Date of Report | 1996-05-08 |
| Date of Event | 1996-04-15 |
| Date Added to Maude | 1996-05-20 |
| 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 | 0 |
| 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 | HIV ANTIGEN ELISA TEST |
| Generic Name | IN VITRO ASSAY FOR BLOOD DONOR SCREENING |
| Product Code | MLH |
| Date Received | 1996-05-14 |
| Model Number | P24 |
| Catalog Number | 933180 |
| Lot Number | 2065K536 |
| ID Number | NA |
| Device Expiration Date | 1996-10-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 34316 |
| Manufacturer | ORTHO DIAGNOSTIC SYSTEMS |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 088690606 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-05-14 |