BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLTRION DIATRUST COVID TEST

    MDR report key: 17922963 · Received October 11, 2023

    Report

    Report Number
    MW5146842
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    October 8, 2023
    Report Date
    October 9, 2023
    Manufacturer
    CELLTRION USA INC./ HUMASIS CO., LTD
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED THE CURRENT CELLTRION DIATRUST COVID TEST (AT HOME TEST) THAT WAS RECENTLY SENT BY THE GOVERNMENT VIA THE USPS WEBSITE. THIS TEST SHOWS AN ALMOST WHITE LINE IN THE "T" PART OF THE TEST RESULT. THE INSTRUCTIONS SAY THE LINE SHOULD BE PINK, HOWEVER THE WHITE LINE SHOWED UP ONCE I WAITED THE INSTRUCTED TIME. CAN YOU TELL ME WHAT THIS MEANS? THE POSITIVE TEST LINE WAS SUPPOSED TO BE PINK, BUT AS YOU CAN SEE IN THE PICTURE IT IS MORE OF AN OFF WHITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768009 CELLTRION DIATRUST COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CELLTRION USA INC./ HUMASIS CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female