MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-16 for SOFIA RAPID INFLUENZA A AND B TEST manufactured by Quidel.
[19689764]
Obtained false positive results on the quidel rapid influenza sofia test. Confirmation testing, including two different pcr assays, of the rapid influenza were negative. Reason for use: pneumonia.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5027749 |
MDR Report Key | 2847841 |
Date Received | 2012-11-16 |
Date of Report | 2012-11-16 |
Date of Event | 2012-11-11 |
Date Added to Maude | 2012-11-30 |
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 RAPID INFLUENZA A AND B TEST |
Generic Name | RAPID INFLUENZA A AND B 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 | QUIDEL |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2012-11-16 |