BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 17330494 · Received July 15, 2023

    Report

    Report Number
    3008573045-2023-00035
    Event Type
    Malfunction
    Date Received
    July 15, 2023
    Date of Event
    June 25, 2023
    Report Date
    July 15, 2023
    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

    THERE WAS NO INFORMATION PROVIDED REGARDING THE LOT NUMBER OF THE ANTIGEN TEST KIT; THEREFORE IHEALTH LABS, INC., COULD NOT CONCLUDE IF THE TEST KIT WAS A COUNTERFEIT PRODUCT OR NOT. AS NOTED IN THE IFU, UNDER STEP 6 READ RESULT: RESULTS SHOULD NOT BE READ AFTER 30 MINUTES (RESULTS SHOWS AT 2X MAGNIFICATION). NOTE: A FALSE NEGATIVE OR FALSE POSITIVE RESULT MAY OCCUR IF THE TEST RESULT IS READ BEFORE 15 MINUTES OR AFTER 30 MINUTES. THERE WAS NO INFORMATION PROVIDED REGARDING THE LOT NUMBER OF THE ANTIGEN TEST KIT; COULD NOT CONCLUDE IF THE TEST KIT WAS A COUNTERFEIT PRODUCT OR NOT.

    Description of Event or Problem · 0

    "I HAVE BEEN USING YOUR I HEALTH COVID TESTS PROVIDED BY THE SCHOOLS TO TEST FOR COVID. I TESTED MYSELF YESTERDAY BECAUSE I WAS VERY SICK. TEST WAS NEGATIVE. I WENT TO URGENT CARE YESTERDAY AND IT TURNS OUT I AM POSITIVE FOR COVID. I TESTED MYSELF AGAIN TODAY WITH YOUR AT HOME COVID TEST. STILL SAYS NEGATIVE. I WONDER HOW MANY PEOPLE ARE ACTUALLY GOING TO SCHOOL THAT ARE POSITIVE WITH COVID BECAUSE YOUR TESTS DO NOT WORK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597912 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Unknown