BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLTRION DIATRUST

    MDR report key: 18410042 · Received December 27, 2023

    Report

    Report Number
    MW5149627
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    December 23, 2023
    Report Date
    December 23, 2023
    Manufacturer
    CELLTRION USA, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FALSE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273624 CELLTRION DIATRUST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CELLTRION USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male