BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS DISPENSER 0.5ML

    MDR report key: 939972 · Received April 19, 2007

    Report

    Report Number
    1056600-2007-00099
    Event Type
    Malfunction
    Date Received
    April 19, 2007
    Date of Event
    March 20, 2007
    Report Date
    April 19, 2007
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPENSER WAS NOT RETURNED FOR INVESTIGATION. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. ISSUE RESOLVED VIA PRODUCT REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MTS DISPENSER DID NOT DISPENSE THE CORRECT AMOUNT OF FLUID DURING TESTING. INCORRECT DISPENSE OF FLUID, MAY LEAD TO VARIATIONS IN ANTIGEN / ANTIBODY RATIO AND POSSIBLE ERRONEOUS TEST RESULTS. THE CUSTOMER ABORTED TESTING ONCE THE ISSUE WAS IDENTIFIED. THE DISPENSER WAS TAKEN OUT OF USE, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS DISPENSER 0.5ML MANUAL DISPENSER GJG MICRO TYPING SYSTEMS, INC. NA 40295

    Patients

    Seq Age Sex Outcome Treatment
    1 *