BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 16147069 · Received January 12, 2023

    Report

    Report Number
    3004142665-2023-00007
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 31, 2022
    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

    ON 1/17/2023: THE CONSUMER POSTED A COMMENT ON AN INTELISWAB FACEBOOK POST. THE CONSUMER STATED THEY CONFIRMED THEIR POSITIVE RESULT WITH TWO OTHER TESTS MADE BY DIFFERENT COMPANIES, BUT DID NOT SPECIFY WHAT TYPE OF TEST WAS USED. 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. FACEBOOK POST STATING THEY TESTED NEGATIVE WITH INTELISWAB, BUT TESTED POSITIVE WITH TWO OTHER TESTS. FACEBOOK COMMENT: "WORST TESTS WE HAVE EVER USED. HAD TO WAIT 30 MINS FOR THE RESULTS PER INSTRUCTIONS. EVEN THEN, IT GAVE US A FALSE NEGATIVE. THE POSITIVE RESULT WAS CONFIRMED BY TWO OTHER TESTS MADE BY DIFFERENT COMPANIES. BESIDES, THE BOX IS TOO BULKY AND TAKING UP TOO MUCH SPACE FOR JUST TWO TESTS. LUCKILY, WE DID NOT PAY FOR THE TEST KIT BECAUSE THEY ARE SUCH GARBAGE. AVOID AT ALL COSTS. IF YOU RECEIVE THESE FOR FREE, THROW THEM AWAY."

    Description of Event or Problem · 0

    CONSUMER LEFT A COMMENT ON AN ORASURE TECHNOLOGIES, INC. FACEBOOK POST STATING THEY TESTED NEGATIVE WITH INTELISWAB BUT TESTED POSITIVE WITH TWO OTHER TESTS. FACEBOOK COMMENT: "WORST TESTS WE HAVE EVER USED. HAD TO WAIT 30 MINS FOR THE RESULTS PER INSTRUCTIONS. EVEN THEN, IT GAVE US A FALSE NEGATIVE. THE POSITIVE RESULT WAS CONFIRMED BY TWO OTHER TESTS MADE BY DIFFERENT COMPANIES. BESIDES, THE BOX IS TOO BULKY AND TAKING UP TOO MUCH SPACE FOR JUST TWO TESTS. LUCKILY WE DIDN'T PAY FOR THE TEST KIT BECAUSE THEY ARE SUCH GARBAGE. AVOID AT ALL COSTS. IF YOU RECEIVE THESE FOR FREE, THROW THEM AWAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573031 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown