BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ID TIPMASTER PIPETTOR

    MDR report key: 843448 · Received March 2, 2007

    Report

    Report Number
    1056600-2007-00056
    Event Type
    Malfunction
    Date Received
    March 2, 2007
    Date of Event
    January 31, 2007
    Report Date
    March 2, 2007
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MTS ID TIPMASTER PIPETTOR DISPENSED AND INCORRECT AMOUNT OF FLUID. INCORRET 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 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 *