BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLTRION DIATRUST COVID-19 AG HOME TEST

    MDR report key: 18210464 · Received November 24, 2023

    Report

    Report Number
    MW5148492
    Event Type
    Malfunction
    Date Received
    November 24, 2023
    Date of Event
    November 22, 2023
    Report Date
    November 22, 2023
    Manufacturer
    CELLTRION USA INC. / HUMASIS CO., LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY CELLTRION DIATRUST COVID-19 AM HOME TEST HAD ZERO FILTER TIPS, BUT SHOULD HAVE HAD TWO. THIS DIDN'T CAUSE A PROBLEM FOR ME (EXCEPT NOT HAVING A KIT). NEVERTHELESS, ANOTHER HYPOTHETICAL PERSON WITH THE SAME PRODUCT DEFECT WOULD HAVE A POSSIBLE FALSE RESULT. THE LABEL INDICATES "COVSP2001NA 2023.01.16".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219577 CELLTRION DIATRUST COVID-19 AG HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CELLTRION USA INC. / HUMASIS CO., LTD. CT-P60-D-05 COVSP2001

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male