BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS DISPENSER 1.0MI

    MDR report key: 830134 · Received October 23, 2006

    Report

    Report Number
    1056600-2006-00217
    Event Type
    Malfunction
    Date Received
    October 23, 2006
    Date of Event
    October 8, 2004
    Report Date
    October 23, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT THE CUSTOMER DISCARDED THE INSTRUMENT BEFORE EVALUATION WAS CONDUCTED. THEREFORE, NO ANALYSIS WAS POSSIBLE, AND ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MTS DISPENSER WAS NOT HOLDING FLUID. IF THERE IS AN INCORRECT OR NO DISPENSE EVENT THAT GOES UNDETECTED, ERRONEOUS RESULTS COULD BE REPORTED. 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 1.0MI DISPENSER GJG MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *