BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 17674654 · Received September 1, 2023

    Report

    Report Number
    3008573045-2023-00038
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 7, 2023
    Report Date
    September 1, 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

    INITIAL REPORT SUGGESTED THERE WERE NO MEDICAL INTERVENTION OR TREATMENT PROVIDED; HOWEVER, THE CURRENT STATUS OF THE NUMBER OF PATIENT IS UNKNOWN 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. CUSTOMER/USER MAY HAVE NOT FOLLOWED THE INSTRUCTIONS ACCURATELY, POSSIBLY CAUSING THE POSITIVE TEST RESULT/OUTCOME WHEN THE TEST ANTIGEN KIT WAS USED ALTHOUGH THIS HAS NOT BEEN CONFIRMED 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. CONTINUOUSLY FOLLOW UP ON NEW CUSTOMER FEEDBACK.

    Description of Event or Problem · 0

    THE USER WAS NOTED TO HAVE REPORTED VIA ZENDESK, AS FOLLOWS: " REFUND FOR THERE BEING AN ERROR WITH THE TEST KIT! THEY RESULTS WERE FALSE NEGATIVES BECAUSE I TESTED MYSELF AND MY FATHER AND WE BOTH TESTED NEGATIVE AND WITH OUT PRIMARY PHYSICIAN WE TESTED POSITIVE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713307 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown