MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-25 for ED EZFLU * manufactured by Becton Dickinson.
[452058]
This influenza season, laboratory and laboratories across town and in other parts of the country have experienced false positive results using various brands of influenza a/b immunoassay -rapid tests-. Rptr's laboratory has been using bd ezflu this year, and has found that the influenza b positive specimens do not confirm with culture or rt-pcr. The hosp laboratory across the st tested several specimens with binax now which showed lines for both flua and flub, so they send them to rptr to test with bd ezflu, which also gave lines for flub (strongest) and flua (lighter). Rptr could not isolate a virus from these specimens, not subsequent flub test positive specimens, nor could reference laboratory detect influenza by rt-pcr in these specimens. A colleague in another city using binax, now says she is having the same problem. Earlier in the season, a local hosp lab had false positive influenza b results using remel xpect. Rptr has phoned bd and binax and was told no one else has complained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037842 |
| MDR Report Key | 672796 |
| Date Received | 2006-01-25 |
| Date of Report | 2006-01-25 |
| Date of Event | 2006-01-25 |
| Date Added to Maude | 2006-02-10 |
| 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 | ED EZFLU |
| Generic Name | RAPID IMMUNOASSAY FOR INFLUENZA A AND B |
| Product Code | GRP |
| Date Received | 2006-01-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 662114 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | * SPARKS MD * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-01-25 |