BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLTRION DIATRUST COVID-19 AG HOME TEST

    MDR report key: 18552017 · Received January 19, 2024

    Report

    Report Number
    MW5150578
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    December 22, 2023
    Report Date
    January 16, 2024
    Manufacturer
    HUMASIS INC. / CELLTRION USA, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KN
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON DECEMBER 22, 2023, CELLTRION USA RECEIVED AN EMAIL WITH COMPLAINT OF FALSE NEGATIVE. THE USER EMAILED THAT THE COVID TEST WITH DIATRUST WAS FALSE NEGATIVE BECAUSE THE USER TESTED POSITIVE AT THE DR OFFICE. IMPORTER COMMENTS: CELLTRION USA IS CURRENTLY ACTING AS AN IMPORTER AND DISTRIBUTOR OF THE 'CELLTRION DIATRUST COVID-19 DIAGNOSTIC TEST KIT', WHICH WAS APPROVED UNDER EUA BY USFDA IN 2020. UNTIL NOW, CELLTRION HAS BEEN REPORTED EMDRS TO THE US FDA USING THE MANUFACTURER'S FEI#, BUT THE FEI# WAS RECENTLY CHANGED TO INVALID. THEREFORE, CELLTRION CANNOT IMMEDIATELY REPORT THIS MDR UNTIL THIS ISSUE IS SOLVED. ACCORDINGLY, CELLTRION WILL REPORT MDR THROUGH A VOLUNTARY REPORTING PROCESS INSTEAD OF A MANDATORY REPORTING PROCESS TO SHOW ITS COMMITMENT TO REPORTING. THIS REPORT IS THE INITIAL CASE REPORTED BY THE USER. IF WE GET RECEIVE ADDITIONAL INFORMATION FROM THE USER, WE WILL REPORT TO FDA. [USER INFORMATION: NAME: (B)(6)].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405009 CELLTRION DIATRUST COVID-19 AG HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP HUMASIS INC. / CELLTRION USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown