MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-08-12 for SOFIA INFLUENZA A+B 20218 manufactured by Quidel Corp..
[23180102]
Due to the lot number not being available, manufacturer was unable to perform an investigation. Manufacturer made several attempts to obtain additional info from the complainant. Phone calls and emails were not returned.
Patient Sequence No: 1, Text Type: N, H10
[23180103]
(b)(6). Test was confirmed as (b)(6) by pcr at a state laboratory. Pt was treated and 2 days later was admitted to the hospital as being septic.
Patient Sequence No: 1, Text Type: D, B5
[28045424]
Multiple attempts were made to request additional information, including phone calls and emails. Customer was unresponsive. In response to a request from fda, further attempts were made, and the sales manager was sent to the site to obtain information and provide sd cards so that the analyzer data could be downloaded and forwarded to quidel for review. The assay lot number and analyzer serial number were obtained. In-house testing was performed on retains from the lot in question. Five cassettes each were tested with negative standard, fresh, and in m4, m5, m6 and utm viral transport media. All results passed, and the (b)(6) could not be replicated. The analyzer data was reviewed. The earliest patient result stored in the export log was dated (b)(6) 2015 (event date was (b)(6) 2014). The analyzer holds a maximum of 500 patient results. However, the calibration results ((b)(6) 2014 and (b)(6) 2015) and the qc results ((b)(6) 2014) that bracket the (b)(6) 2014 event date showed the analyzer performing as expected. The device history record for this lot was reviewed and no issues were noted that would contribute to a (b)(6) result. Complaint data for this lot and the last year were reviewed - no trend was identified.
Patient Sequence No: 1, Text Type: N, H10
[28045445]
A (b)(6) was obtained on (b)(6) 2014, and later confirmed as (b)(6) by pcr (asku - asked but unavailable). Patient was prescribed tamiflu and sent home. Patient returned to the emergency department on (b)(6) 2014 and was admitted to a children's specialty hospital. Blood cultures were drawn and were reported as (b)(6) on (b)(6) 2014. Patient died on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024674-2015-00001 |
| MDR Report Key | 5003407 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-08-12 |
| Date of Report | 2015-10-09 |
| Date of Event | 2014-12-27 |
| Date Mfgr Received | 2015-09-24 |
| Device Manufacturer Date | 2014-10-10 |
| Date Added to Maude | 2015-08-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER RIAL |
| Manufacturer Street | 12544 HIGH BLUFF DRIVE, #200 SUITE 200 |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal | 92130 |
| Manufacturer Phone | 8585521100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFIA INFLUENZA A+B |
| Generic Name | SOFIA INFLUENZA A+B |
| Product Code | GNX |
| Date Received | 2015-08-12 |
| Model Number | NA |
| Catalog Number | 20218 |
| Lot Number | 108166 |
| Device Expiration Date | 2016-05-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| 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; 2. Hospitalization | 2015-08-12 |