BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST

    MDR report key: 17950070 · Received October 16, 2023

    Report

    Report Number
    MW5147047
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    October 8, 2023
    Report Date
    October 11, 2023
    Manufacturer
    HEALGEN SCIENTIFIC LLC
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST DID NOT WORK. THE VIAL INTENDED TO SQUEEZE LIQUID DROPS ONTO THE TEST DEVICE RELEASED ONLY FOAM, NOT LIQUID. THIS HAPPENED TWICE. THE TEST ENDED UP BEING INVALID - THE CONTROL LINE DID NOT APPEAR. REF REPORT: MW5147048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82808 CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP HEALGEN SCIENTIFIC LLC 2202599EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female