BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 12727555 · Received November 1, 2021

    Report

    Report Number
    3004142665-2021-00012
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 30, 2021
    Report Date
    November 1, 2021
    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

    CONSUMER POSTED REVIEW ON WALGREENS.COM. NO FOLLOWUP IS TO BE EXPECTED WITH THE COMPLAINT FILE AND THE INCIDENT WILL BE CLOSED INTERNALLY. CORRECTED THE REPORT TO INCLUDE THE EUA NUMBER, FULL DEVICE DESCRIPTION NAME AND A CORRECTED PHONE NUMBER AS REQUESTED.

    Description of Event or Problem · 0

    CONSUMER LEFT A REVIEW ON WALGREENS.COM THAT THEY TESTED NEGATIVE USING INTELISWAB. CONSUMER WENT TO THE ER TO GET TESTED AND RESULTS WERE POSITIVE. WALGREENS.COM REVIEW 10/30/2021 50% RIGHT ON COVID TEST TESTED NEGATIVE. MY HUSBAND WAS POSITIVE SO WE TOOK HIM TO THE ER. WHILE THERE THEY TESTED US BOTH AGAIN AND WE WERE BOTH POSITIVE. 50% ISN'T A VERY GOOD AVERAGE AS TO HOW YOUR TESTS WORK.

    Description of Event or Problem · 0

    CONSUMER LEFT A REVIEW ON (B)(6) THAT THEY TESTED NEGATIVE USING INTELISWAB. CONSUMER WENT TO THE ER TO GET TESTED AND RESULTS WERE POSITIVE. (B)(6) REVIEW (B)(6) 2021 50% RIGHT ON COVID TEST TESTED NEGATIVE. MY HUSBAND WAS POSITIVE SO WE TOOK HIM TO THE ER. WHILE THERE THEY TESTED US BOTH AGAIN AND WE WERE BOTH POSITIVE. 50% ISN'T A VERY GOOD AVERAGE AS TO HOW YOUR TESTS WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624640 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown