BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON/GO COVID-19 ANTIGEN SELF-TEST

    MDR report key: 13981173 · Received April 1, 2022

    Report

    Report Number
    3003966368-2022-00122
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    February 14, 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. ANTIGEN TEST THAT SUBJECT #1 OF 3 PERFORMED MIGHT YIELD FALSE POSITIVE RESULT. IN ORDER TO IDENTIFY THE TRUE ROOT CAUSE OF THIS ALLEGATION, ACCESS BIO NEEDS TO FURTHER COMMUNICATE WITH SUBJECT#1 OF 3 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

    3 PACKS (6 TESTS) ALL READ NEGATIVE BUT LAB TESTS SHOW POSITIVE. MY FAMILY AND I ALL TOOK A TEST AND SHOWED NEGATIVE. FOLLOWING DAY DID RAPID LAB TESTS AND WE WERE ALL POSITIVE ON LAB RESULTS SO WE HAD 3 MORE TESTS. I WAS LIKE LET'S TEST AGAIN JUST TO SEE. ALL CAME OUT NEGATIVE AGAIN. THIS WAS NOT A "BAD BATCH" AS IT HAPPENS IN MANUFACTURING AND I UNDERSTAND THAT HAPPENS SOMETIMES BUT 3 DIFFERENT BOXES WITH DIFFERENT MANUFACTURING DATES AND EXPIRATION DATES ALL BEING WRONG. NOT A FLUKE OR COINCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239500 ON/GO COVID-19 ANTIGEN SELF-TEST COVID-19 ANTIGEN SELF-TEST QKP ACCESS BIO INCORPORATE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown