BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS DISPENSER 0.5 ML

    MDR report key: 785883 · Received November 16, 2006

    Report

    Report Number
    1056600-2006-00283
    Event Type
    Malfunction
    Date Received
    November 16, 2006
    Date of Event
    August 22, 2005
    Report Date
    November 16, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT AND THE DEVICE IN QUESTION WAS DISCARDED. NO EVALUATION WAS PERFORMED PRIOR TO DISPOSAL. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED THAT THE MTS 0.5 ML DISPENSER DID NOT DISPENSE THE CORRECT VOLUME. INCORRECT DISPENSE VOLUME MAY LEAD TO ERRONEOUS TEST RESULTS AND THE POSSIBILITY OF TRANSFUSION OF INCOMPATIBLE BLOOD. THERE WAS NO REPORT OF HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS DISPENSER 0.5 ML DISPENSER GJG MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *