MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-15 for SOFIA RSV FIA manufactured by Quidel Corp..
[108283007]
Patient Sequence No: 1, Text Type: N, H10
[108283008]
Noted increased positivity for respiratory syncytial virus (rsv) using sofia analyzer. When retested with the biofire polymerase chain reaction (pcr), the rsv were negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7513709 |
| MDR Report Key | 7513709 |
| Date Received | 2018-05-15 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-03-29 |
| Report Date | 2018-05-10 |
| Date Reported to FDA | 2018-05-10 |
| Date Reported to Mfgr | 2018-05-10 |
| Date Added to Maude | 2018-05-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFIA RSV FIA |
| Generic Name | ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS |
| Product Code | GQG |
| Date Received | 2018-05-15 |
| Returned To Mfg | 2018-04-10 |
| Lot Number | 127533 |
| Device Expiration Date | 2019-11-17 |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CORP. |
| Manufacturer Address | 10165 MCKELLAR COURT SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-15 |