BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 19247933 · Received May 6, 2024

    Report

    Report Number
    3008573045-2024-00015
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 6, 2024
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    PMA / PMN Number
    EUA210470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1.AS OF 05/03/2024, IHEALTH LABS[?]INC ARE CURRENTLY WAITING FOR THE RETURNED PRODUCT FOR A FURTHER INVESTIGATION. CUSTOMER SERVICE IDENTIFIED AN EXTRA EJECTION MOLD WHICH RAISED COUNTERFEIT SUSPICION. IN ADDITION, CUSTOMERS RECEIVING A POSITIVE RESULT BY USING WATER FURTHER POINTS TO THE INAUTHENTICITY OF THE TEST. 2.ON 03/11/2024, THE MANUFACTURING FACTORY CONDUCTED A TEST ON THE (LOT 231CO21013) SAMPLE, AND THE TEST RESULT SHOWED A NEGATIVE TEST COMPLIANCE RATE OF 100%

    Description of Event or Problem · 0

    EVENT DETAILS:(ZD324577) I BOUGHT ONE OF YOUR TEST KITS THAT HAD 2 KITS IN 1 BOX. THE FIRST TEST SHOWED A POSITIVE TEST. I FOUND IT VERY HARD TO BELIEVE. SO I TOOK THE SECOND TEST KIT & PUT 3 PLAIN DROPS IN THE TEST PAD LIKE YOU ARE SUPPOSED TO, I DID NOTHING WITH SWABBING MY NOSE. I PUT THE 3 DROPS DIRECTLY IN THE TEST PAD & WAITED MY 15 MINUTES & IT CAME OUT POSITIVE. IT WAS THE PLAIN SOLUTION DROPS OUT OF YOUR LIQUID CONTAINER THAT CAME IN THE BOX THAT TESTED POSITIVE. SO SOMETHING IS VERY WRONG, BECAUSE BOTH TEST PADS TESTED POSITIVE. ONE WAS NOSE SWABBED & THE OTHER ONE WAS THE PLAIN WATER SOLUTION THAT CAME IN YOUR LITTLE DROPPER CONTAINER. THIS MAKES NO SENSE TO ME AS TO WHY THESE BOTH TESTS ARE COMING OUT THE SAME & THAT IS POSITIVE. I BOUGHT THIS TEST KIT AT THE (B)(6) IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751378 IHEALTH Coronavirus antigen detection test system. QKP ANDON MEDICAL CO.,LTD ICO-3000 231CO21013

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Unknown