BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 18949446 · Received March 21, 2024

    Report

    Report Number
    3008573045-2024-00011
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 27, 2024
    Report Date
    March 21, 2024
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    PMA / PMN Number
    EUA210470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER PROVIDED WAS LOT # 231C020908, EXPIRATION 2024-12-07. SINCE THIS PRODUCT WAS PROVIDED BY AMAZON AND THERE ARE NO REPORTS OF NON-AUTHENTIC OCCURRENCES OF THIS LOT NUMBER. IT IS DETERMINED THAT THIS IS EITHER A RESULT OF HUMAN ERROR OR LOW VIRAL LOAD IN THE SAMPLE AREA DURING THE TIME OF THE TEST. SUSPECTS THAT THE FALSE NEGATIVE TEST IS DUE TO THE LOW VIRAL LOAD THE CUSTOMER HAD EARLIER IN THE WEEK ((B)(6) 2024) WHEN THE TEST WAS TAKEN. ON SATURDAY (B)(6) 2024 WHEN THE VIRAL LOAD WAS THE HIGHEST WAS WHEN THE CUSTOMER RECEIVED A POSITIVE COVID TEST FROM IHEALTH AND ANOTHER BRAND (FASTEP). THERE WAS NO CONFIRMATION WITH A PCR TEST AND THE CUSTOMER HAD SELF REPORTED COVID SYMPTOMS. TEST TO LOT: 231CO20908 BATCH OF PRODUCT RETENTION SAMPLES,THE TEST RESULT IS QUALIFIED.

    Description of Event or Problem · 0

    EVENT DETAILS: HI - MY WIFE RECENTLY BOUGHT COVID RAPID TESTS THAT WERE SUPPOSEDLY FROM IHEALTH ON AMAZON, BUT THESE ARE ALMOST CERTAINLY COUNTERFEIT. IN THE SUSPECTED TESTS THE CONTROL LINE WAS VERY FAINT AND THE WELL FOR DROPS COULD NOT HOLD A FULL DROP AND PERHAPS THE PRINTING WAS VERY SLIGHTLY LOWER QUALITY. BUT MOST IMPORTANTLY THE TESTS DID NOT WORK. MY WIFE HAD COVID AND I HAD KNOWN EXPOSURE AND WAS GETTING VERY SICK. MULTIPLE TESTS OVER SEVERAL DAYS KEPT SHOWING NEGATIVE. WHEN I USED A DIFFERENT BOX OF IHEALTH TESTS THAT I WE HAD ALREADY THE POSITIVE LINE SHOWED IMMEDIATELY. HAPPY TO SHARE ANY FURTHER INFORMATION. THIS WAS A HUGE PROBLEM FOR ME AND A PUBLIC HEALTH ISSUE, SO PLEASE LET ME KNOW WHAT I CAN DO TO HELP YOU RESOLVE THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892532 IHEALTH Coronavirus antigen detection test system. QKP ANDON MEDICAL CO.,LTD ICO-3000 231CO20908

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male