BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 14875204 · Received June 30, 2022

    Report

    Report Number
    3008573045-2022-00135
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 30, 2022
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    UDI-DI
    00208563205894
    PMA / PMN Number
    EUA210470
    Removal / Correction Number
    MW5110093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRESPONDING TO THE PRODUCTION BATCH OF PRODUCT RETENTION SAMPLES (LOT:211CO21215), THE NEGATIVE COINCIDENCE RATE TEST WAS CARRIED OUT, AND THE TEST RESULTS SHOWED THAT THE NEGATIVE COINCIDENCE RATE WAS 100%.NO FALSE POSITIVES FOUND.FOLLOW-UP WITH THE INITIAL REPORTER MOMENTARILY TO INQUIRE THE FOLLOWING UP TO AND INCLUDING ACTUAL PATIENTS TESTED POSITIVE FOR COVID-19, ACTUAL LOT NUMBER FOR KITS USED FOR PATIENTS TESTED NEGATIVE FOR COVID-19, REQUEST TO HAVE THE UNUSED KITS RETURNED TO IHEALTH FOR FURTHER INVESTIGATION, IDENTIFY IF ALL OF THE KITS USED WERE OF (B)(6) MANUFACTURED PRODUCTS, STATUS/CONDITION ON 4 PATIENTS CONFIRMED +, AND IF ANY MEDICAL INTERVENTION WAS PROVIDED TO THOSE + CASES PATIENTS. THE CASES PATIENTS HAVE UTILIZED LOT NUMBER: 211CO21215, SUSPECTED COUNTERFEIT PRODUCTS.

    Description of Event or Problem · 0

    WE TOOK RAPID TESTS AT REQUEST OF OUR DENTIST. NO ONE HAD SYMPTOMS. TESTS FROM ONE LOT ALL TESTED POSITIVE. FROM ANOTHER LOT ALL NEGATIVE. WE GOT PCR TESTS THAT WERE ALL NEGATIVE. THIS SEEMS TO BE A· LOT OF RAPID COVID TESTS THAT ARE GIVING FALSE POSITIVES. WE HAD 4 POSITIVE RAPID TESTS FROM THE SAME LOT 211CO21215. WE HAD NEGATIVE RAPID TESTS FROM A DIFFERENT LOT. AND NEGATIVE PCR TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2397389 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 211CO21215 00208563205894

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female