BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIATRUSTTM COVID-19 AG HOME TEST

    MDR report key: 15496096 · Received September 28, 2022

    Report

    Report Number
    3008719759-2022-00130
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    September 17, 2022
    Report Date
    September 27, 2022
    Manufacturer
    HUMASIS CO., LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON SEPTEMBER 17, AN AMAZON CUSTOMER COMMENTED THAT THE PRODUCT WAS INACCURATE: CUSTOMER ORDERED THESE PRODUCTS BECAUSE THE USER THOUGHT THEY WOULD BE USEFUL TESTS, SUCH AS 'ON THE GO' RAPID TESTS OR 'IHEALTH ANTIGEN TESTS. DESPITE THE POSITIVE RESULTS FROM BINAX, THE RESULTS OF THIS PRODUCT (DIATRUST) WERE NEGATIVE. IMPORTER COMMENTS: DUE TO THE SYSTEM FUNCTIONALITY TO NOT ALLOW SELLER CAN LEAVE THE COMMENTS ON THE WEB SITE OR CONTACT THE REPORTER, IT IS NOT ABLE FOR US TO FOLLOW UP TO COLLECT ADDITIONAL INFORMATION AND SUCH AS PRODUCT INFORMATION (LOT #, EXPIRATION DATE, ETC.) AND ANY EVIDENCE OF PCR RESULT TO PROVE FALSE RESULT ETC FOLLOWING BY REPORTER'S CONSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952870 DIATRUSTTM COVID-19 AG HOME TEST IN VITRO DIAGNOSTICS QKP HUMASIS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown