MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-27 for QUICKVUE INFLUENZA A+B 20183 manufactured by Quidel Corporation.
[181318449]
Manufacturer tested in-house influenza a and influenza b low-level positive standard on retains and returns of the affected product. All tests yielded accurate and valid results at the 10 minute result read time, product performed properly. Review of the manufacturing records found no issues that would lead to a false negative result. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[181318450]
Very sick patient came into the clinic on jan 22 and tested negative for flu with quickvue test. He was prescribed azithromycin because they believed he had pneumonia. On jan 23, a check-in was performed and he stated he was feeling better. On jan 24th, 9:45 am, he called in reporting to feel worse and dehydrated. He drove to the hospital (b)(6) medical center and arrived to the er at 2:56 pm. He tested positive for flu a on molecular test (solana) and died later that day due to cardiac arrest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024674-2020-00002 |
| MDR Report Key | 9766131 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-27 |
| 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 | FRANK POKROP |
| Manufacturer Street | 10165 MCKELLAR COURT |
| Manufacturer City | SAN DIEGO, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 3020477 |
| Manufacturer G1 | QUIDEL CORPORATION |
| Manufacturer Street | 10165 MCKELLAR COURT |
| Manufacturer City | SAN DIEGO, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKVUE INFLUENZA A+B |
| Generic Name | QUICKVUE FLU TEST |
| Product Code | PSZ |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-14 |
| Model Number | 20183 |
| Catalog Number | 20183 |
| Lot Number | 705526 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CORPORATION |
| Manufacturer Address | 10165 MCKELLAR COURT SAN DIEGO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-27 |