BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLTRION DIATRUST COVID 19 ANTIGEN TEST

    MDR report key: 15437843 · Received September 15, 2022

    Report

    Report Number
    MW5112071
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    September 14, 2022
    Report Date
    September 14, 2022
    Manufacturer
    CELLTRION USA INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    [CELLTRION DIATRUST ] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): COVID 19 ANTIGEN TEST LOT COVGCA 1005 EXPIRATION DATE NOV 2, 2022 IS GENERATING FALSE NEGATIVE RESULTS AT 15 MINUTES READ TIME, AS PER INSERT. INITIALLY DETECTED FAINT POSITIVE RESULT AFTER 1 HOUR (INSERT INDICATES READ TIME 15 MINUTES) . SUBSEQUENT PATIENTS TESTED POSITIVE ON HOME TESTING DEVICES, RESULTS WERE NEGATIVE ON CELLTRION DIATRUST KIT, INDICATED TEST KIT. SAMPLE WAS RETESTED ON ALTERNATE COVID 19 ANTIGEN KIT (ALLERE BINAX NOW) OBTAINED POSITIVE RESULTS AS PER PACKAGE INSERT. BINAX NOW FROM ALLERE COINCIDES WITH PATIENT RESULT OBTAINED ON HOME TEST KIT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522727 CELLTRION DIATRUST COVID 19 ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CELLTRION USA INC. COVGCA 1005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown