BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE

    MDR report key: 16148334 · Received January 11, 2023

    Report

    Report Number
    MW5114282
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    January 9, 2023
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE NOW USED TWO SEPARATE BOXES OF QUICKVUE AT HOME COVID TESTS FROM QUIDEL CORPORATION. I FOLLOWED UP WITH MY BINAX TEST. MY BINAX TEST, I GET POSITIVE READING. I HAD COVID THIS WEEK. WHEN I TESTED WITH QUICKVUE AT THE SAME TIME, QUICKVUE IS NOT SHOWING ACCURATE RESULTS. IT SHOWS ME AS NEGATIVE. I AM NOT NEGATIVE. CONFIRMED POSITIVE ON TWO OTHER BRANDS. QUICKVUE NEEDS TO BE TAKEN OFF MARKET. TESTED TWICE; 2 DAYS IN A ROW, WITH LOT NUMBER F41146, 2 SEPARATE BOXES SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073888 QUICKVUE CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORPORATION F41146
    2073889 QUICKVUE CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORPORATION F41146

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female