BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLTRION DIATRUST COVID-19 AG HOME TEST

    MDR report key: 18119722 · Received November 9, 2023

    Report

    Report Number
    MW5148014
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    November 5, 2023
    Report Date
    November 7, 2023
    Manufacturer
    CELLTRION USA INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CELLTRION DIATRUST COVID-19 AG HOME TEST. UPC# 8 806121 763235 LOT#(I THINK)COVSB2005NA 2023.01.25 OTHER NUMBERS:REV=01=12=22 IC=2739; I RECEIVED TWO OF THESE KITS THROUGH USPS THIS LAST OFFER ABOUT 1 MONTH AGO. BOTH KITS ARE MISSING ONE TEST TUBE (EXTRACTION BUFFER) AND FILTER KIT. THE TEST CAN'T BE COMPLETED WITHOUT THIS COMPONENT. THE SEAL WAS INTACT ON BOTH PACKAGES. I HAVE THE KITS IF YOU NEED THEM. REFERENCE REPORT: MW5148015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944203 CELLTRION DIATRUST COVID-19 AG HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CELLTRION USA INC. COVSB2005NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female