BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 16149909 · Received January 12, 2023

    Report

    Report Number
    3004142665-2023-00008
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    January 4, 2023
    Report Date
    January 12, 2023
    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

    1/17/2023- THE CONSUMER POSTED A COMMENT ON AN INTELISWAB FACEBOOK POST. 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 THEIR FAMILY MEMBERS DAUGHTER RECEIVED A FALSE RESULT USING INTELISWAB. COMMENT: "THESE TESTS GIVE FALSE READINGS. MY COUSIN DID MULTIPLE AT HOME TESTS FOR HER DAUGHTER N EVERYONE CAME BACK NEGATIVE. SYMPTOMS KEPT GETTING WORSE BY THE 2ND DAY AT SCHOOL. TOOK HER TO A CLINIC N FULL BLOW POSITIVE. BY THE END OF THE WEEK HER DAUGHTER'S ENTIRE CLASS WAS OUT SICK WITH COVID"

    Description of Event or Problem · 0

    CONSUMER LEFT A COMMENT ON AN ORASURE TECHNOLOGIES, INC. INTELISWAB FACEBOOK POST STATING THEIR FAMILY MEMBERS DAUGHTER RECEIVED A FALSE RESULT USING INTELISWAB. COMMENT: THESE TESTS GIVE FALSE READINGS. MY COUSIN DID MULTIPLE AT HOME TESTS FOR HER DAUGHTER N EVERYONE CAME BACK NEGATIVE. SYMPTOMS KEPT GETTING WORSE BY THE 2ND DAY AT SCHOOL. TOOK HER TO A CLINIC N FULL BLOW POSITIVE. BY THE END OF THE WEEK HER DAUGHTER'S ENTIRE CLASS WAS OUT SICK WITH COVID"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512812 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown