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

Model Number 20183

Device Problem False Negative Result (1225)

Patient Problems Death (1802); Sudden Cardiac Death (2510)

Event Date 01/22/2020

Event Type  Death  

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 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
• Type of Device: QUICKVUE FLU TEST
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar court; san diego, ca
• Manufacturer (Section G): QUIDEL CORPORATION; 10165 mckellar court; san diego, ca
• Manufacturer Contact: frank pokrop ; 10165 mckellar court; san diego, ca ; 3020477
• MDR Report Key: 9766131
• MDR Text Key: 181318449
• Report Number: 2024674-2020-00002
• Device Sequence Number: 1
• Product Code: PSZ
• UDI-Device Identifier: 30014613201830
• UDI-Public: 30014613201830
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 88