BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 18229229 · Received November 29, 2023

    Report

    Report Number
    3004142665-2023-00045
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 22, 2023
    Report Date
    December 6, 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

    THE CONSUMER REPORTED FALSE NEGATIVE INTELISWAB TEST RESULTS IN THEIR AMAZON.COM REVIEW. SPECIFIC DETAILS OF THE COLLECTION AND TESTING PROCESS OF THE INTELISWAB TESTS WERE NOT PROVIDED. THE CONSUMER ALSO DID NOT PROVIDE A LOT NUMBER OR ANY OTHER PRODUCT INFORMATION. IT IS UNKNOWN IF A PCR TEST WAS USED TO CONFIRM THE TEST RESULTS. ORASURE TECHNOLOGIES, INC. IS UNABLE TO CONTACT THE CONSUMER FOR ADDITIONAL INFORMATION AS NO CONTACT INFORMATION IS AVAILABLE ON AMAZON.COM. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THIS COMPLAINT AND THE INCIDENT WILL BE CLOSED INTERNALLY.

    Description of Event or Problem · 0

    CONSUMER LEFT AN AMAZON REVIEW FOR INTELISWAB CLAIMING FALSE NEGATIVE RESULTS. AMAZON REVIEW 'THESE SUCK I TOOK 4 OF THESE TESTS. 3 NEGATIVES OVER SEVERAL DAYS AND 1 WITH JUST NOTHING. I USED A DIFFERENT TEST AND IT WAS POSITIVE.' THE CONSUMER RECEIVED THREE FALSE NEGATIVE TEST RESULTS USING THREE SEPARATE INTELISWAB DEVICES. REFER TO THE BELOW MANUFACTURER REPORT NUMBERS FOR THE ADDITIONAL FALSE NEGATIVE SUBMISSIONS: MDR # 3004142665-2023-00043 MDR # 3004142665-2023-00044.

    Description of Event or Problem · 0

    CONSUMER LEFT AN AMAZON REVIEW FOR INTELISWAB CLAIMING FALSE NEGATIVE RESULTS. AMAZON REVIEW 'THESE SUCK I TOOK 4 OF THESE TESTS. 3 NEGATIVES OVER SEVERAL DAYS AND 1 WITH JUST NOTHING. I USED A DIFFERENT TEST AND IT WAS POSITIVE.' THE CONSUMER RECEIVED THREE FALSE NEGATIVE TEST RESULTS USING THREE SEPARATE INTELISWAB DEVICES. REFER TO THE BELOW MANUFACTURER REPORT NUMBERS FOR THE ADDITIONAL FALSE NEGATIVE SUBMISSIONS: MDR # 3004142665-2023-00043 MDR # 3004142665-2023-00044

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98056 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown