BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKVUE INFLUENZA A+B

    MDR report key: 9766131 · Received February 27, 2020

    Report

    Report Number
    2024674-2020-00002
    Event Type
    Death
    Date Received
    February 27, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 3, 2020
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    PSZ
    UDI-DI
    30014613201830
    PMA / PMN Number
    K180288
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228572 QUICKVUE INFLUENZA A+B QUICKVUE FLU TEST PSZ QUIDEL CORPORATION 20183 705526 30014613201830

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death