BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON/GO COVID-19 ANTIGEN SELF-TEST

    MDR report key: 13981073 · Received April 1, 2022

    Report

    Report Number
    3003966368-2022-00112
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    January 31, 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 NEGATIVE RESULTS DISCOVERED THROUGH AMAZON REVIEW ARE FOLLOWING: 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 BEFORE 10 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. F. EXCESSIVE BUFFER APPLICATION TO SAMPLE WELL OF TEST DEVICE. 3. COMPLAINANT MIGHT NOT USE THE TEST IN ACCORDNACE WITH ITS INTENDED USE A. TESTING OUTSIDE OF FIRST 7 DAYS OF SYMPTOM ONSET B. TAKING HIGH DOSES OF BIOTIN (> 10 MG PER DAY) 4. 13% OF FALSE NEGATIVE RESULTS ARE EXPECTED BASED ON PERFORMANCE CHARACTERISTICS CLAIMED FOR THIS TEST (87% PPA). 5. TESTS MIGHT BE EXPOSED TO EXTREME ENVIRONMENTAL CONDITIONS DURING STORAGE. 6. PCR TEST THAT THE COMPLAINANT PERFORMED MIGHT YIELD FALSE NEGATIVE RESULT. 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

    TESTED NEGATIVE AT LEAST 5 TIMES VIA THIS PRODUCT. I AM IN HEALTHCARE AND KNOW HOW TO SWAB. HAD A PCR TODAY DUE TO UPCOMING MINOR SURGICAL PROCEDURE. PCR AT 11:30 AM POSITIVE BY 7PM. TOOK ANOTHER HOME TEST FROM THIS COMPANY AFTER POSITIVE PCR - AND AGAIN - NEGATIVE. DESPITE CLEARLY POSITIVE PCR, I CONTINUE TO TEST NEGATIVE - OVER AND OVER WITH THIS HOME TEST. 3 NEGATIVE HOME TESTS WITH 2 POSITIVE PCRS IN A ROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761699 ON/GO COVID-19 ANTIGEN SELF-TEST COVID-19 ANTIGEN SELF-TEST QKP ACCESS BIO INCORPORATE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown