BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12681406 · Received October 21, 2021

    Report

    Report Number
    MW5104830
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 18, 2021
    Report Date
    October 19, 2021
    Manufacturer
    QUIDEL CORP.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I GAVE MY SON THE QUICKVIEW AT-HOME OTC COVID-19 TEST. HE TESTED POSITIVE FOR COVID-19. I DID A SECOND TEST WITH THE BINACTS TEST, AND THAT ONE TESTED NEGATIVE. I THEN TOOK HIM FOR AN OFFICIAL PCR TEST OFFERED THROUGH THE COUNTY. I JUST GOT THE TEST RESULTS BACK, AND THEY WERE NEGATIVE. THE QUICKVIEW TEST WAS A FALSE POSITIVE. I STILL HAVE THE BOX, AND THE LOT NUMBER IS 706812. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567962 QUICKVUE AT-HOME OTC COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP QUIDEL CORP. 706812

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR