BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 AG

    MDR report key: 17906581 · Received October 6, 2023

    Report

    Report Number
    MW5146761
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 4, 2023
    Manufacturer
    CELLTRION USA INC. / HUMASIS CO. LTD
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHY WOULD YOU BOTHER SENDING OUT COVID TESTS IN (B)(6) THAT ARE GOING TO EXPIRE IN (B)(6)? CELLTRION COVID-19 AG COVSP2003NB (B)(6) 2023 WHICH HAS AN EXTENDED EXPIRATION DATE OF JUST 2024-01-18. NOT A GOOD LOOK FOR YOU AT ALL. ALSO WHY SEND OUT TESTS THAT ARE FOR 14 YEARS & OLDER WITHOUT ASKING ABOUT THE RECIPIENTS' AGES? WHAT IS MY 5 YEAR OLD GRANDSON SUPPOSED TO USE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237482 COVID-19 AG CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CELLTRION USA INC. / HUMASIS CO. LTD CT-P60 D-2 05 COVSP2003NB

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other