BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 16448356 · Received February 27, 2023

    Report

    Report Number
    3004142665-2023-00016
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 10, 2023
    Report Date
    February 27, 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 POSTED A COMMENT ON AN INTELISWAB FACEBOOK POST. THE CONSUMER DID NOT PROVIDE A LOT NUMBER OR OTHER PRODUCT INFORMATION. ORASURE TECHNOLOGIES,INC. IS UNABLE TO CONTACT THE CONSUMER DIRECTLY AS NO CONTACT INFORMATION WAS PROVIDED. 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 A COMMENT ON AN ORASURE TECHNOLOGIES, INC. FACEBOOK POST CLAIMING TWO FALSE NEGATIVE RESULTS. FACEBOOK COMMENT: (B)(6) 'I HAD IT TWICE AND IT WAS NEGATIVE TWICE'. REFER TO MFR REPORT# 3004142665-2023-00015 FOR FIRST FALSE NEGATIVE SUBMISSION.

    Description of Event or Problem · 0

    CONSUMER LEFT A COMMENT ON AN ORASURE TECHNOLOGIES, INC. FACEBOOK POST CLAIMING TWO FALSE NEGATIVE RESULTS. FACEBOOK COMMENT: ADA CUERVO ROCIO. 'I HAD IT TWICE AND IT WAS NEGATIVE TWICE'. REFER TO MFR REPORT# 3004142665-2023-00015 FOR FIRST FALSE NEGATIVE SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657135 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown