BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 14875152 · Received June 30, 2022

    Report

    Report Number
    3008573045-2022-00136
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 11, 2022
    Report Date
    June 30, 2022
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    UDI-DI
    00208563205894
    PMA / PMN Number
    EUA210470
    Removal / Correction Number
    MW5110301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1.THE CUSTOMER DOES NOT PROVIDE SPECIFIC BATCH INFORMATION, AND CANNOT CONFIRM THE TRUE CONDITION OF THE PRODUCT OR TEST THE RESERVED SAMPLE. 2.CUSTOMERS BUY THROUGH SUNLINE(HTTPS://SUNLINESUPPLY.COM/SHOP/TEST-KITS/COVID-OTC-RAPID-ANTIGEN-TEST-KITSIHEALTH-BOX-OF-2-TESTS-CARTON/), BUT SUNLINE DID NOT OBTAIN IHEALTH'S AUTHORIZATION TO DISTRIBUTE IHEALTH PRODUCTS IN THE US. 3.IHEALTH LABS DEMAND THAT SUNLINE SUPPLY IMMEDIATELY:1. REMOVE IHEALTH COVID-19 ANTIGEN RAPID TEST ON YOUR WEBSITE;2. PROVIDE INFORMATION REGARDING YOUR SUPPLIER OF IHEALTH COVID-19 ANTIGEN RAPID TEST, INCLUDING BUT NOT LIMITED TO, ANY TRANSACTION DOCUMENTS, SHIPPING DOCUMENTS, COMMUNICATION RECORDS, ETC.3. PROVIDE YOUR INVENTORY RECORDS (NUMBER OF TEST KITS RELATED TO EACH LOT#)

    Description of Event or Problem · 0

    COMPLAINT INFORMATION: ORDERED TWO CASES OF 180 IHEALTH COVID-19 ANTIGEN TESTS FROM SUNLINE SUPPLY FOR USE BY OUR THEATREEMPLOYEES. OUR COVID COMPLIANCE OFFICER REPORTED THAT 45% OF THE TESTS FROM SUNLINE SUPPLY CAMEOUT BLANK, WITH NO CONTROL LINE, AND MANY HAD REAGENT TUBES THAT WERE EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301412 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 00208563205894

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male