BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON/GO COVID-19 ANTIGEN SELF-TEST

    MDR report key: 13981174 · Received April 1, 2022

    Report

    Report Number
    3003966368-2022-00121
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    January 20, 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 RESULTS DISCOVERED THROUGH AMAZON REVIEW ARE FOLLOWING: COMPLAINANT MIGHT MISINTERPRET TEST RESULTS. COMPLAINANT MIGHT NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU). INADEQUATE SAMPLE COLLECTION. INTERPRETING RESULTS BEFORE 10 MINUTES. NOT PERFORMING TEST IMMEDIATELY AFTER OPENING THE TEST DEVICE IN THE POUCH. POTENTIAL CONTACT WITH FOREIGN SUBSTANCES AND HOUSEHOLD CLEANING PRODUCTS DURING SAMPLE COLLECTION AND TESTING. OPERATING TEST OUTSIDE OF STORAGE CONDITIONS. EXCESSIVE BUFFER APPLICATION TO SAMPLE WELL OF TEST DEVICE. COMPLAINANT MIGHT NOT USE THE TEST IN ACCORDANCE WITH ITS INTENDED USE: TESTING OUTSIDE OF FIRST 7 DAYS OF SYMPTOM ONSET TAKING HIGH DOSES OF BIOTIN (> 10 MG PER DAY) SINGLE TEST FOR ASYMPTOMATIC PATIENT INADEQUATE SERIAL TESTING FOR ASYMPTOMATIC PATIENT 13% OF FALSE NEGATIVE RESULTS ARE EXPECTED BASED ON PERFORMANCE CHARACTERISTICS CLAIMED FOR THIS TEST (87% PPA). 2% OF FALSE POSITIVE RESULTS ARE EXPECTED BASED ON PERFORMANCE CHARACTERISTICS CLAIMED FOR THIS TEST (98% NPA). TESTS MIGHT BE EXPOSED TO EXTREME ENVIRONMENTAL CONDITIONS DURING STORAGE. IT'S UNCLEAR HOW THE COMPLAINANT VERIFIED FALSE 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, BUT THIS WOULD BE DIFFICULT DUE TO GIVEN LIMITED INFORMATION AVAILABLE AND INABILITY OF ACCESS BIO TO INVESTIGATE FACTS AND CIRCUMSTANCES.

    Description of Event or Problem · 0

    THIS ITEM DOES NOT WORK. IT GIVES FALSE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239501 ON/GO COVID-19 ANTIGEN SELF-TEST COVID-19 ANTIGEN SELF-TEST QKP ACCESS BIO INCORPORATE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown