MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-24 for SOFIA RSV FIA 20260 manufactured by Quidel Corporation.
[178260454]
The following investigation steps were performed: testing: the customer returned tests from kit lot #705337 (pouch lot #135981). Five (5) returned devices were testing with rsv low-level positive standard. All five (5) returned devices tested with rsv low-level positive standard yielded 100% valid and positive results at the 15 minute result read time. Device history record (dhr) review: a review of the dhr was conducted and no issues were noted. The devices were released in accordance to their specifications. Analyzer log data review: an analysis of the returned log data was performed. Four (4) tests were conducted with pouch lot #135981: two (2) tests had positive results and two(2) tests had negative results. The customer reported that the patient was tested on (b)(6) 2019 and again on (b)(6) 2019; no patient id was provided. The logs show that on the reported dates, there was only one rsv test performed on each of those dates and both tests were negative. Although sofia rsv is a qualitative test, quantitative values are recorded in the log. The quantitative valued are for information only, and they do not fully represent the test. For the test performed on (b)(6) 2019, the signal to cutoff (s/co) value = 0. 26, and for the test performed on (b)(6) 2019, the s/co value was 0. 25. S/co values below 1. 0 on sofia will be reported as negative. The s/co values and dates for the two positive results in the log data were 26. 13 on (b)(6) 2019 and 45. 25 on (b)(6) 2019. Trend data: trend analysis was performed for the sofia rsv. No trend was identified. Conclusion: we tested the returned devices with the rsv low-level positive standard in our qc laboratory, and the devices yielded 100% valid and positive results at the 15 minute result read time. Log data review shows that sofia rsv performed correctly. The s/co negative values support that negative results were noted on (b)(6). A review of the manufacturing data showed that product passed all tests and was released in accordance to our specification. Trend analysis was performed and no fn trend was identified for this lot, and these were the only two fns. Although we were unable to duplicate the complaint, the information provided has been documented and will continue to be monitored as part of our quality system.
Patient Sequence No: 1, Text Type: N, H10
[178260455]
On (b)(6), an infant with rsv-like symptoms tested negative for rsv at the er and was sent home. On (b)(6) the infant was brought back to the er and tested negative for rsv again. The patient was then transferred same day to (b)(6) and was tested with the biofire rp panel. The pcr came back positive for rsv. The infant developed pneumonia and was rushed into the icu same day (12/26) was released on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024674-2020-00001 |
| MDR Report Key | 9627958 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-24 |
| Date of Report | 2019-12-27 |
| Date of Event | 2019-12-25 |
| Date Mfgr Received | 2019-12-27 |
| Device Manufacturer Date | 2019-06-26 |
| Date Added to Maude | 2020-01-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS JENNIFER RIAL |
| Manufacturer Street | 10165 MCKELLAR COURT |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8585527910 |
| Manufacturer G1 | QUIDEL CORPORATION |
| Manufacturer Street | 10165 MCKELLAR COURT |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFIA RSV FIA |
| Generic Name | RSV TEST |
| Product Code | GQG |
| Date Received | 2020-01-24 |
| Model Number | 20260 |
| Lot Number | 705337 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CORPORATION |
| Manufacturer Address | 10165 MCKELLAR COURT SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-24 |