BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLTRION DIATRUST COVID-19 AG HOME TEST

    MDR report key: 18256714 · Received December 1, 2023

    Report

    Report Number
    MW5148678
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 30, 2023
    Report Date
    November 30, 2023
    Manufacturer
    CELLTRION USA, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NO BUFFER SOLUTION BOTTLE INCLUDED. CELLTRION DIATRUST COVID-19 AG HOME TEST. COULDN'T COMPLETE DUE TO MISSING SOLUTION. NOW WE ARE SICK AND HAVE NO TEST KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064670 CELLTRION DIATRUST COVID-19 AG HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CELLTRION USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown