BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX COVID RAPID TEST

    MDR report key: 12331477 · Received August 16, 2021

    Report

    Report Number
    MW5103272
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    August 12, 2021
    Report Date
    August 13, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED BINAX RAPID COVID TEST WHICH WAS NEGATIVE ON (B)(6) 2021. A PCR PERFORMED THAT SAME DAY WAS POSITIVE. REPEATED TEST ON DAY 5 OF ILLNESS AND WAS STILL NEGATIVE. I'VE PREVIOUSLY BEEN VACCINATED SO AM WONDERING IF THAT IS A REASON WHY THE BINAX WAS A FALSE NEGATIVE. THERE NEED TO BE STUDIES OF THESE TESTS IN PREVIOUSLY VACCINATED INDIVIDUALS TO BETTER UNDERSTAND IF PRIOR COVID VACCINATION MAY REDUCE THE SENSITIVITY OF THESE TESTS, AS MANY OF US HEALTH CARE WORKERS RELY ON THESE TO DETERMINE SAFETY OF OUR FAMILIES (INCLUDING THOSE NOT ABLE TO BE VACCINATED BECAUSE YOU ARE UNNECESSARILY DRAGGING YOUR HEELS ON EXPANDING THE EAPS FOR CHILDREN). NOT REQUIRING ONGOING SENSITIVITY ANALYSES IN THE VACCINATED POPULATION IS AS IRRESPONSIBLE AS YOUR REFUSAL TO MOVE FORWARD WITH EXPANDING VACCINE EAPS FOR CHILDREN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226635 BINAX COVID RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    1226636 BINAX COVID RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR