BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GONOCHEK-II

    MDR report key: 10321 · Received November 10, 1993

    Report

    Report Number
    2917572-1993-00007
    Event Type
    Malfunction
    Date Received
    November 10, 1993
    Date of Event
    October 5, 1993
    Report Date
    October 15, 1993
    Manufacturer
    EY LABORATORIES (H.K.) LTD.
    Product Code
    GTH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CONFIRMED NEISSERIA GONORRHOEAE FAILED TO PRODUCE A POSITIVE (RED COLOR) REACTION IN GONOCHEK-II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GONOCHEK-II IN-VITRO DIAGNOSTIC TEST-NEISSERIA GONORRHOEAE GTH EY LABORATORIES (H.K.) LTD. N/A 100427

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other