MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-24 for CAMBRIDGE BIOTECH HIV-1 WESTERN BLOT * 98002 manufactured by Cambridge Biotech/calypte Biomedical.
[205093]
Samples collected for routine hiv screening that were repeatedly reactive using an fda approved eia exhibited robin egg speckling when tested using the fda approved western blot. Some samples were resolved using a different lot number; however, other samples were not resolved. The mfr was consulted and was able to reproduce the problem, but no explanation was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018010 |
| MDR Report Key | 260139 |
| Date Received | 2000-01-24 |
| Date Added to Maude | 2000-01-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CAMBRIDGE BIOTECH HIV-1 WESTERN BLOT |
| Generic Name | WESTERN BLOT STRIPS |
| Product Code | MVW |
| Date Received | 2000-01-24 |
| Model Number | * |
| Catalog Number | 98002 |
| Lot Number | C9281 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 251944 |
| Manufacturer | CAMBRIDGE BIOTECH/CALYPTE BIOMEDICAL |
| Manufacturer Address | 1500 E. GUDE DR. ROCKVILLE MD 20850 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-01-24 |