BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 16582546 · Received March 21, 2023

    Report

    Report Number
    3008573045-2023-00015
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    July 8, 2022
    Report Date
    March 21, 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 (NO PATIENT DEATH, INJURY, ALLERGIC REACTION(S), OR ANY MEDICAL INTERVENTION PROVIDED). 2. LOT NUMBER: 223CO20124 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. 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. 5. TEST TO THE PRODUCTION BATCH OF PRODUCT RETENTION SAMPLES (LOT: 223CO20124 ) , THE TEST WAS PASS.

    Description of Event or Problem · 0

    THE USER WAS NOTED TO HAVE REPORTED VIA VOICEMAIL, AS FOLLOWS: "CAN YOU TELL ME WHY I HAVE TAKEN FIVE IHEALTH ANTIGEN RAPID TESTS SIMULTANEOUSLY WITH BINAXNOW ANTIGEN TESTS HOURS AND DAYS APART AND ALL, FIVE, OF MY IHEALTH TESTS WERE FALSE-NEGATIVES? THE BINAXNOW ANTIGEN TESTS SHOWED I WAS POSITIVE AND THE VALIDITY OF THE BINAXNOW TESTS WERE VALIDATED ON WEDNESDAY THROUGH A "SIMULTANEOUS" PCR TEST. IS IHEALTH DUMPING FAULTY COVID-19 TESTS ON THE MARKET TO ELIMINATE FINANCIAL LOSSES THROUGH CHARITABLE TAX BREAKS? THESE FALSE POSITIVES ARE KEEPING COVID POSITIVE PEOPLE, UNKNOWINGLY, CIRCULATING AMONGST OUR UNINFECTED POPULACE SPREADING SPREADING COVID 19. YOUR TESTS ARE A HEALTH HAZARD AND NEED TO BE REMOVED FROM THE MARKET AND SHOULD NOT BE DISTRIBUTED EVEN IF THEY ARE FREE. YOUR COMPANY SHOULD NOT BE GETTING A TAX BREAKS FOR THE "CHARITY". I AM POSTING THIS ON MY FACEBOOK PAGE AND WILL ESCALATE THIS MATTER IF I DON'T GET A SATISFACTORY ANSWER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24077 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 223CO20124

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown