BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ID TIPMASTER PIPETTOR

    MDR report key: 970202 · Received May 10, 2007

    Report

    Report Number
    1056600-2007-00128
    Event Type
    Malfunction
    Date Received
    May 10, 2007
    Date of Event
    April 13, 2007
    Report Date
    May 10, 2007
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPETTE IS NO LONGER COVERED UNDER WARRANTY. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE USE OF THIS INSTRUMENT. THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION AND THE ROOT CAUSE OF THIS EVENT IS UNK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MTS ID TIPMASTER PIPETTOR DRIPPED FLUID PRIOR TO TESTING. FLUID DRIP FROM THE PIPETTOR CAN LEAD TO CARRY OVER/CROSS CONTAMINATION AND INCORRECT DISPENSE OF FLUID WHICH MAY LEAD TO VARIATIONS IN ANTIGEN/ANTIBODY RATIO AND POSSIBLE ERRONEOUS TEST RESULTS. THE CUSTOMER ABORTED TESTING ONCE THE ISSUE WAS IDENTIFIED. THE PIPETTOR WAS TAKEN OUT OF USE, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ID TIPMASTER PIPETTOR MANUAL PIPETTOR GJG MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *