BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 15484806 · Received September 26, 2022

    Report

    Report Number
    3004142665-2002-00029
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    September 19, 2022
    Report Date
    September 21, 2022
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONSUMER POSTED A COMMENT ON FACEBOOK.COM. NO ADDITIONAL FOLLOW UP IS TO EXPECTED WITH THE COMPLAINT FILE AND THE COMPLAINT WILL BE CLOSED INTERNALLY.

    Description of Event or Problem · 0

    THE FOLLOWING COMMENT WAS LEFT ON AN (B)(4). INTELISWAB FACEBOOK POST: (B)(6), (B)(6), THIS TEST IS NOT ACCURATE AT ALL. I HAVE 2 DIFFERENT RAPID TEST. THIS TEST SAID NEGATIVE AND OTHER TEST SAID POSITIVE. PCR CONFIRMED POSITIVE TOO'.

    Description of Event or Problem · 0

    THE FOLLOWING COMMENT WAS LEFT ON AN ORASURE TECHNOLOGIES, INC. INTELISWAB FACEBOOK POST: RINA CHU. 'BARB BARUTH PALLA THIS TEST IS NOT ACCURATE AT ALL. I HAVE 2 DIFFERENT RAPID TEST. THIS TEST SAID NEGATIVE AND OTHER TEST SAID POSITIVE. PCR CONFIRMED POSITIVE TOO'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2934289 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown