BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIATRUSTTM COVID-19 AG RAPID TEST

    MDR report key: 15626009 · Received October 18, 2022

    Report

    Report Number
    3008719759-2022-00140
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 14, 2022
    Report Date
    October 18, 2022
    Manufacturer
    HUMASIS CO., LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, FDA ISSUED A MEDWATCH LETTER TO MANUFACTURER AND CELLTRION USA, INC. DUE TO A VOLUNTARY SPONTANEOUS REPORT (MW5112071) FOR CELLTRION DIATRUST COVID AG RAPID TEST. THIS LETTER WAS RECEIVED ON OCT 07 VIA COURIER. THE CONSUMER SAID THAT THE PRODUCT WAS FALSE NEGATIVE AT 15 MINUTES AND DETECTED FAINT POSITIVE RESULT AFTER 1 HOUR, DESPITE THE INSTRUCTIONS DESCRIBING A DETECTION TIME OF 15 MINUTES. SUBSEQUENT PATIENTS HAVE TESTED POSITIVE ON HOME TESTING DEVICES, THE RESULTS WERE NEGATIVE ON CELLTRION DIATRUST KIT, THE SAMPLE WAS RETESTED ON ALTERNATE COVID-19 ANTIGENT KIT (ALLERE BINAX NOW) AND POSITIVE RESULTS OBTAINED AS PER PACKAGE INSERT. FDA SAFETY REPORT ID# (B)(4). AND THE INITIAL REPORTER HAS ASSIGNED 'HEALTEH-EFFECT-CLINICAL CODE(S)' AS 2248 (VIRAL INFECTION) IN THE SECTION "DEVICE MANUFACTURER ONLY". IMPORTER COMMENTS: AS INITIAL REPORTER'S CONSENT TO FOLLOW UP BY IMPORTER IT IS NOT ABLE FOR US TO FOLLOW UP TO CONFIRM ANY EVIDENCE OF PCR RESULT TO PROVE FALSE RESULT ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351077 DIATRUSTTM COVID-19 AG RAPID TEST IN VITRO DIAGNOSTICS QKP HUMASIS CO., LTD. COVGCA 1005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown