MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-10 for ATHENA MULTILYTE * manufactured by Wampole.
[20932549]
This is to report a problem with a laboratory assay - non life threatening-the performance characteristics of the athena wampole/zues multilyte kit for ana screening does not at all correlate with patient history, signs and symptoms. The kit is designed to detect lupus or other connective tissue disease associated antibodies. As a "screening" method it has very poor correlation with pt presentation. This method has a sensitivity level well beyond what is considered normal, thereby detecting the presence of antibodies, especially rnp, and to a lessor extent, ss-b, scl-70 and jo-1. Rptr's laboratory has for the last 3 months routinely run these specimens by secondary method only to have very few "confirm" with what would be a high false positivity rate. For diagnosed lupus pts this test works well, however does not seem to be designed for screening "all comers. " rptr has unsuccessfully convinced the mfr that there is a problem. They refuse to confirm issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037711 |
| MDR Report Key | 663816 |
| Date Received | 2006-01-10 |
| Date of Report | 2006-01-10 |
| Date Added to Maude | 2006-01-17 |
| 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 | 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 | ATHENA MULTILYTE |
| Generic Name | ANA TEST |
| Product Code | DHN |
| Date Received | 2006-01-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 653238 |
| Manufacturer | WAMPOLE |
| Manufacturer Address | 2 RESEARCH WAY PRINCETON NJ 08540 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-01-10 |