MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-28 for SOFIA INFLUENZA A+B FIA 20218 manufactured by Quidel Corp..
[17131517]
A (b)(6)-male in poor health was admitted to the emergency room and died shortly after arrival. Patient nasopharyngeal wash/aspirate sample was tested with sofia influenza a+b fia and produced a positive influenza b result. Sample was retested and produced a negative result. Sample also tested negative with a different rapid test. Patient tested positive for strep a blood culture.
Patient Sequence No: 1, Text Type: D, B5
[17406790]
Initial reporter stated that no other patient history was available, and the patient records could not be obtained from the family.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024674-2012-00001 |
| MDR Report Key | 2903679 |
| Report Source | 05 |
| Date Received | 2012-12-28 |
| Date of Report | 2012-12-17 |
| Date of Event | 2012-11-27 |
| Date Mfgr Received | 2012-11-27 |
| Device Manufacturer Date | 2012-06-29 |
| Date Added to Maude | 2013-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 10165 MCKELLAR CT. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8585527910 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFIA INFLUENZA A+B FIA |
| Generic Name | SOFIA INFLUENZA A+B FIA |
| Product Code | GNX |
| Date Received | 2012-12-28 |
| Model Number | NA |
| Catalog Number | 20218 |
| Lot Number | 212222 |
| ID Number | NA |
| Device Expiration Date | 2014-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CORP. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2012-12-28 |