MAUDE Adverse Event Report: QUIDEL CORPORATION QUICKVUE INFLUENZA A+B; QUICKVUE FLU TEST

Model Number	20183
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Death (1802); Sudden Cardiac Death (2510)
Date of Event	01/22/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: QUICKVUE INFLUENZA A+B
• Common Device Name: QUICKVUE FLU TEST
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar court; san diego, ca
• MDR Report Key: 9766131
• Report Number: 2024674-2020-00002
• Device Sequence Number: 13625365
• Product Code: PSZ
• UDI-Device Identifier: 30014613201830
• UDI-Public: 30014613201830
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2022
• Device Model Number: 20183
• Device Catalogue Number: 20183
• Device Lot Number: 705526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Weight: 88