MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-16 for SOFIA INFLUENZA A AND B RAPID TEST manufactured by Guidel.
[2999660]
Obtained false positive results on the quidel rapid influenza sofia test. Confirmation testing, including two different pcr assays, of the rapid influenza were negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027750 |
| MDR Report Key | 2847831 |
| Date Received | 2012-11-16 |
| Date of Report | 2012-11-16 |
| Date of Event | 2012-11-11 |
| Date Added to Maude | 2012-11-29 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFIA INFLUENZA A AND B RAPID TEST |
| Generic Name | INFLUENZA A AND B RAPID TEST |
| Product Code | GNX |
| Date Received | 2012-11-16 |
| Returned To Mfg | 2012-11-15 |
| Lot Number | 212239 |
| Device Expiration Date | 2014-01-27 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GUIDEL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-16 |