BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH COVID-19 ANTIGEN RAPID TEST

    MDR report key: 14695020 · Received June 14, 2022

    Report

    Report Number
    MW5110304
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    June 13, 2022
    Report Date
    June 13, 2022
    Manufacturer
    ANDON MEDICAL CO., LTD
    Product Code
    QKP
    UDI-DI
    00856362005890
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NO DILUENT/STERILE MEDIA PROVIDED TO CONDUCT TESTING FOR KITS, MULTIPLE PACKAGES. BRAND: IHEALTH MODEL: ICO-3001, LOT NO.(10): 223CO20214, EXP:2022-08-13. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659035 IHEALTH COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ANDON MEDICAL CO., LTD ICO-3000 223CO20214 00856362005890

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male