BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON/GO COVID-19 ANTIGEN SELF-TEST

    MDR report key: 13980916 · Received April 1, 2022

    Report

    Report Number
    3003966368-2022-00129
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    January 28, 2022
    Report Date
    April 1, 2022
    Manufacturer
    ACCESS BIO INCORPORATE
    Product Code
    QKP
    PMA / PMN Number
    EUA210314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    POSSIBLE ROOT CAUSES OF SUSPECTED FALSE POSITIVE RESULTS DISCOVERED THROUGH AMAZON REVIEWS ARE FOLLOWINGS: 1. COMPLAINANT MIGHT MISINTERPRET TEST RESULTS. 2. COMPLAINANT MIGHT NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU) A. INADEQUATE SAMPLE COLLECTION (EXCESS BLOOD OR MUCUS ON SWAB). B. INTERPRETING RESULT AFTER 15 MINUTES. C. NOT PERFORMING TEST IMMEDIATELY AFTER OPENING THE TEST DEVICE IN THE POUCH. D. POTENTIAL CONTACT WITH FOREIGN SUBSTANCES AND HOUSEHOLD CLEANING PRODUCTS DURING SAMPLE COLLECTION AND TESTING. E. OPERATING TEST OUTSIDE OF STORAGE CONDITIONS. 3. COMPLAINANT MIGHT NOT PERFORM THE TEST IN ACCORDANCE WITH ITS INTENDED USE. A. INADEQUATE SERIAL TESTING FOR AYMPTOMATIC PATIENT. 4. 2% OF FALSE POSITIVE RESULTS ARE EXPECTED BASED ON PERFORMANCE CHARACTERISTICS CLAIMED FOR THIS TEST (98% NPA). 5. IT'S UNCLEAR HOW THE COMPLAINANT VERIFIED THE FALSE POSITIVE RESULTS OF ON/GO COVID-19 ANTIGEN SELF-TEST. IN ORDER TO IDENTIFY THE TRUE ROOT CAUSE OF THIS ALLEGATION, ACCESS BIO NEEDS TO FURTHER COMMUNICATE WITH THE COMPLAINANT TO RULE OUT ABOVE POTENTIAL ROOT CAUSES. IN THE ABSENCE OF THE PERSONAL INFORMATION AND INABILITY TO COMMUNICATE WITH THE COMPLAINANT, IT WOULD BE DIFFICULT TO RULE OUT POTENTIAL ROOT CAUSES IDENTIFIED ABOVE.

    Description of Event or Problem · 0

    GAVE TWO FALSE POSITIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761692 ON/GO COVID-19 ANTIGEN SELF-TEST COVID-19 ANTIGEN SELF-TEST QKP ACCESS BIO INCORPORATE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown