BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 16139058 · Received January 11, 2023

    Report

    Report Number
    3004142665-2023-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 25, 2022
    Report Date
    January 11, 2023
    Manufacturer
    ORASURE TECHNOLIGIES, 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 AND ORASURE TECHNOLOGIES, INC. FACEBOOK POST STATING THEY USED INTELISWAB ON THEIR DAUGHTER AND RECEIVED A FALSE NEGATIVE RESULT. FACEBOOK COMMENT: "NOPE. USED THESE ON MY DAUGHTER- KEPT SAYING NEGATIVE.. WENT TO THE DOCTOR CAUSE SHE KEPT GETTING FEVERS- POSITIVE. DECIDED TO TRY AND TEST AGAIN WHILE SHE WAS STILL POSITIVE AND IT STILL SHOWED UP AS NEGATIVE. IM GOOD.

    Description of Event or Problem · 0

    CONSUMER LEFT A COMMENT ON AND ORASURE TECHNOLOGIES, INC. FACEBOOK POST STATING THEY USED INTELISWAB ON THEIR DAUGHTER AND RECEIVED A FALSE NEGATIVE RESULT. FACEBOOK COMMENT: "NOPE. USED THESE ON MY DAUGHTER- KEPT SAYING NEGATIVE.. WENT TO THE DOCTOR CAUSE SHE KEPT GETTING FEVERS- POSITIVE. DECIDED TO TRY AND TEST AGAIN WHILE SHE WAS STILL POSITIVE AND IT STILL SHOWED UP AS NEGATIVE. IM GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420304 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLIGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown