BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 15161804 · Received August 4, 2022

    Report

    Report Number
    3008573045-2022-00194
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 26, 2022
    Report Date
    August 4, 2022
    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

    NO MEDICAL INTERVENTION OR TREATMENT HAS BEEN PROVIDED; HOWEVER, THE CURRENT STATUS OF THE USER/PATIENT WAS UNKNOWN TO DATE. LOT NUMBER: 221CO20120 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 IFU STATES A FALSE NEGATIVE OR INVALID RESULT MAY OCCUR IF TOO LITTLE SOLUTION IS ADDED TO THE TEST CARD. 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 INDICATION TO CONFIRM OR DENY IF THE USER/PATIENT HAD UTILIZED THE TEST KIT APPROPRIATELY AS PER INTENDED USE OR OFF USE. 4TEST TO THE PRODUCTION BATCH OF PRODUCT RETENTION SAMPLES (LOT:221CO20120) , THE TEST WAS PASS.

    Description of Event or Problem · 0

    EVENT :THE SITE/USER WAS NOTED TO HAVE REPORTED VIA EMAIL, AS FOLLOWS: "HELLO THIS IS A BAD BATCH OF COVID TESTS. THE FIRST ONE DIDN'T WORK. THE NEXT 2 CAME OUT NEGATIVE EVEN THOUGHT I AM POSITIVE. I THINK THERE'S SOMETHING WRONG WITH THIS SET OF TESTS. I WOULD LIKE TO HAVE MY MONEY BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870542 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 221CO20120

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Hospitalization