MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-11 for SOFIA INFLUENZA A AND B FIA KIT 20218 manufactured by Quidel Corp.
[16880017]
Three pts were tested for influenza b starting (b)(6) 2012 and each received false positive results. Confirmation of false positive results was performed through two additional test methods. There are no known adverse consequences. Caller states there has been a recall instituted (b)(4) 2012 for this device, but the specific lot number used for this test was not listed in the recall.
Patient Sequence No: 1, Text Type: D, B5
[16959410]
Three pts were tested for influenza b starting (b)(6) 2012 and each received false positive results. Confirmation of false positive results was performed through two additional test methods. There are no known adverse consequences. Caller states there has been a recall instituted (b)(4) 2012 for this device, but the specific lot number used for this test was not listed in the recall.
Patient Sequence No: 2, Text Type: D, B5
[16959414]
Three pts were tested for influenza b starting (b)(6) 2012 and each received false positive results. Confirmation of false positive results was performed through two additional test methods. There are no known adverse consequences. Caller states there has been a recall instituted (b)(4) 2012 for this device, but the specific lot number used for this test was not listed in the recall.
Patient Sequence No: 3, Text Type: D, B5
| Report Number | MW5028061 |
| MDR Report Key | 2871763 |
| Date Received | 2012-12-11 |
| Date of Report | 2012-12-11 |
| Date of Event | 2012-07-01 |
| Date Added to Maude | 2012-12-17 |
| 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 | 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 FIA KIT |
| Generic Name | TESTING KIT |
| Product Code | GNX |
| Date Received | 2012-12-11 |
| Catalog Number | 20218 |
| Lot Number | 214851 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CORP |
| Manufacturer Address | MCKELLAR CT SAN DIEGO CA 92121 US 92121 |
| Brand Name | SOFIA INFLUENZA A AND B FIA KIT |
| Generic Name | CASSETTE |
| Product Code | GNX |
| Date Received | 2012-12-11 |
| Lot Number | 214755 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CORP |
| Manufacturer Address | MCKELLAR CT SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-11 | |
| 2 | 0 | 2012-12-11 | |
| 3 | 0 | 2012-12-11 |