BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 16185871 · Received January 17, 2023

    Report

    Report Number
    3004142665-2023-00010
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    January 12, 2023
    Report Date
    January 17, 2023
    Manufacturer
    ORASURE TECHNOLOGIES, INC
    Product Code
    QKP
    PMA / PMN Number
    EUA210378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONSUMER LEFT A REVIEW ON AMAZON.COM STATING THAT THEY RECEIVED A POSITIVE RESULT USING THE INTELISWAB TEST THEN WENT TO THE DOCTOR AND TESTED NEGATIVE. ORASURE TECHNOLOGIES, INC REACHED OUT TO AMAZON IN AN ATTEMPT TO CONTACT THE CONSUMER. ORASURE TECHNOLOGIES, INC IS UNABLE TO CONTACT CONSUMER PER AMAZON DIRECTIVES. NO FURTHER ACTION IS TO BE EXPECTED WITH THIS COMPLAINT AND IT WILL BE CLOSED INTERNALLY.

    Description of Event or Problem · 0

    CONSUMER LEFT AN AMAZON REVIEW FOR INTELISWAB ON (B)(6) 2023 STATING THE FOLLOWING: I USED THIS THE SAME MORNING I HAD A DOCTORS APPOINTMENT. I WAS FEELING SICK LATELY AND WAS VERY CONCERNED I HAD COVID. THIS TEST SHOWED POSITIVE. ONCE I GOT TO MY DOCTORS OFFICE, THEY TESTED ME FOR COVID AND IT CAME BACK NEGATIVE. VERY DISAPPOINTED IN THIS TEST KIT. I TRUST MY DOCTOR MORE THAN AN ONLINE KIT.

    Description of Event or Problem · 0

    CONSUMER LEFT AN AMAZON REVIEW FOR INTELISWAB ON JANUARY 13TH, 2023 STATING THE FOLLOWING: I USED THIS THE SAME MORNING I HAD A DOCTORS APPOINTMENT. I WAS FEELING SICK LATELY AND WAS VERY CONCERNED I HAD COVID. THIS TEST SHOWED POSITIVE. ONCE I GOT TO MY DOCTORS OFFICE, THEY TESTED ME FOR COVID AND IT CAME BACK NEGATIVE. VERY DISAPPOINTED IN THIS TEST KIT. I TRUST MY DOCTOR MORE THAN AN ONLINE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426455 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown