BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 17581216 · Received August 20, 2023

    Report

    Report Number
    3008573045-2023-00036
    Event Type
    Malfunction
    Date Received
    August 20, 2023
    Date of Event
    July 31, 2023
    Report Date
    August 19, 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

    1.NO REPORTS OF ADVERSE RELATED EVENTS WITH EITHER PATIENT OR USER . 2.LOT NUMBER: 221CO20901 HAS NOT BEEN IDENTIFIED BY IHEALTH LABS, INC., AS A COUNTERFEIT PRODUCT, SO IT IS SAFE TO CONCLUDE THAT THE DEVICE/KIT RECEIVED IS A VALID IHEALTH LABS, INC., MANUFACTURED TEST KIT PRODUCT. 3.INITIAL REPORTS SUGGESTED THAT THE IHEALTH ANTIGEN TEST KIT WAS NOT TAMPERED WITH, ALTERED, OR COMPROMISED, AS NO EVIDENCE THAT THE USER/PATIENT HAD SEEN EVIDENCE OF PRODUCT ALTERATION. 4.A FALSE NEGATIVE RESULT MAY OCCUR IF THE TEST RESULT IS READ BEFORE 15 MINUTES OR AFTER 30 MINUTES. 5.TEST TO THE PRODUCTION BATCH OF PRODUCT RETENTION SAMPLES, TEST OF LOT: 221CO20901 WAS PASS.

    Description of Event or Problem · 0

    THE USER BOUGHT 4 BOXES OF YOUR TESTS ON AMAZON (TWO DIFFERENT LOTS). DESPITE BEING SYMPTOMATIC AND HAVING A KNOWN EXPOSURE I TESTED NEGATIVELY REPEATEDLY ON THE LOT WITH THE 08/31/2023 EXPIRATION DATE. THIS MORNING I TESTED ON A LOT WITH AB 04/2024 EXPIRATION DATE AND TESTED POSITIVE. USING THE SAME VIAL THAT I TESTED POSITIVE ON I USED ONE OF THE CARDS FROM THE OLDER LOT AND IT AGAIN WAS NEGATIVE. I AM SINCERELY DISAPPOINTED BECAUSE NOW I MAY HAVE EXPOSED MY 4 MONTH OLD ASSUMING I WAS NEGATIVE AND WE SENT OUR DAUGHTER TO CAMP EXPOSING HER ENTIRE BUNK BECAUSE WE ASSUMED SHE WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126812 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 221CO20901

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown