BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 19666178 · Received July 3, 2024

    Report

    Report Number
    3008573045-2024-00018
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    January 2, 2024
    Report Date
    June 20, 2024
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    PMA / PMN Number
    EUA210470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER SENT PICTURE OF THE TEST CARDS SHOWING POSITIVE RESULTS AND IMAGES OF TWO BOXES SHOWING LOT NUMBERS 234CO20310 (USE BY (B)(6) 2024) AND 234CO20422 (USE BY (B)(6) 2024) THE CUSTOMER ALSO PROVIDED AN IMAGE OF THE TEST RESULTS PERFORMED AT THE PHYSICIAN'S OFFICE ON (B)(6) 2023 AND (B)(6) 2023 BOTH INDICATING THAT ANTIGEN TESTS WERE USED BOTH TIMES SHOWING NEGATIVE RESULTS. THE TEST BRAND WAS NOT DISCLOSED. IHEALTH LABS HAS FOUND THAT THE LOT # 234CO20310 AND LOT # 234CO20422 HAS NOT BEEN ASSOCIATED WITH A NON-AUTHENTIC PRODUCT NOR DID THE CUSTOMER INDICATE TAMPERING. THE CUSTOMER DID NOT IDENTIFY THE SOURCE OF THE PRODUCT.IHEALTH LABS HAVE THE CUSTOMER ON (B)(6) 2024 TO SEND US THE USED AND UNUSED PRODUCT, BUT THE CUSTOMER HAS NOT REPLIED.THE CUSTOMER HADN'T TAKEN A PCR TEST. THE MANUFACTURER RETESTED THE LOT ( 234CO20310) SAMPLE AND THE TEST RESULT WAS QUALIFIED.

    Description of Event or Problem · 0

    EVENT DETAILS: I'VE HAD SEVERAL ISSUES WITH YOUR COVID TEST GIVING ME POSITIVE RESULTS. I WENT TO A CLINIC TO DOUBLE CHECK, AND THEY WERE SAYING I WAS NEGATIVE. PLEASE GIVE ME A CALL BACK, BECAUSE THIS IS SEVERAL TIMES I'VE HAD ISSUES WITH THIS PRODUCT AND YOU NEED TO CHECK IT BECAUSE IT'S REALLY UPSETTING TO PEOPLE TO GET A POSITIVE READING AND THEN FIND OUT THAT YOU DO NOT HAVE COVID. PLEASE GET BACK WITH ME. THIS IS VERY IMPORTANT. (VOICE TO TEXT TRANSLATION AS BEEN CORRECTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756173 IHEALTH Coronavirus antigen detection test system. QKP ANDON MEDICAL CO.,LTD ICO-3000 234CO20310

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Unknown