BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 15438437 · Received September 16, 2022

    Report

    Report Number
    3004142665-2022-00026
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    September 12, 2022
    Report Date
    September 16, 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

    9/16- REVISED TO CORRECT A TYPO IN EVENT.

    Additional Manufacturer Narrative · 0

    9/16- REVISED TO CORRECT A TYPO IN SECTION B5 CONSUMER POSTED A REVIEW ON FACEBOOK.COM. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THE COMPLAINT FILE AND THE INCIDENT WILL BE CLOSED INTERNALLY.

    Description of Event or Problem · 0

    CONSUMER LEFT A COMMENT ON AN ORASURE TECHNOLOGIES, INC. INTELISWAB FACEBOOK POST STATING: "MY SON CAME WAS GIVEN A PCR TEST WHICH CAME BACK POSITIVE, WE HAD ONE OF THESE TOOK IT THE SAME DAY AND IT CAME BACK NEGATIVE. I REALLY DOUBT THE EFFECTIVENESS OF THESE AT HOME TESTS."

    Description of Event or Problem · 0

    CONSUMER LEFT A COMMENT ON AN ORASURE TECHNOLOGIES, INC. INTELISWAB FACEBOOK POST STATING: "MY SON CAME WAS GIVEN A PCR TEST WHICH CAME BACK POSITIVE, WE HAD ONE OF THESE TOOK IT THE SAME DAY AND IT CAME BACK NEGATIVE. I REALLY DOUBT THE EFFECTIVENESS OF THESE AT HOME TESTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124372 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown