MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-26 for WAMPOLE CLEARVIEW KIT 6340RCV manufactured by Wampole.
[508042]
The microbiology lab at hospital was doing correlation studies on the "wampole clearview" plu a/b lateral flow test - a 15-minute test for influenza types a and b with excellent sensitivity and specificity. The product claims high sensitivity and specificity. In the hosp's very short comparison they found very poor performance. The test line was very difficult to read on known positive samples to the point if they did not know the sample was positive it would have been difficult to interpret. Hosp stopped the study after testing only 15 samples. Compared performance to both the binax now kit and the remel expect, both had good perforomance. The test kit appears to be an exact copy of the remel expect kit, just distributed by a different name. However, the performance is not the same as the remel kit. Rptr tried the kit because they assumed it was the same as the remel kit, but at a much lower price.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037020 |
| MDR Report Key | 747192 |
| Date Received | 2005-10-26 |
| Date of Report | 2005-10-26 |
| Date of Event | 2004-12-05 |
| Date Added to Maude | 2006-08-15 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAMPOLE |
| Generic Name | WAMPOLE CLEARVIEW FLU A/B LATERAL FLOW TEST -INFLUENZA A/B- |
| Product Code | GRP |
| Date Received | 2005-10-26 |
| Model Number | CLEARVIEW KIT |
| Catalog Number | 6340RCV |
| Lot Number | NOT RECORDED |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734970 |
| Manufacturer | WAMPOLE |
| Manufacturer Address | 2 RESEARCH WAY PRINCETON NJ 08540 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-26 |