BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ID TIPMASTER PIPETTOR

    MDR report key: 805569 · Received January 5, 2007

    Report

    Report Number
    1056600-2007-00006
    Event Type
    Malfunction
    Date Received
    January 5, 2007
    Date of Event
    December 8, 2006
    Report Date
    January 4, 2007
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 TO MTS AS SUCH NO EVALUATION COULD BE DONE. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD OBSERVED AN INCORRECT AMOUNT OF FLUID DISPENSED FROM THE MTS ID TIPMASTER PIPETTOR. INCORRECT DISPENSE OF FLUID MAY LEAD TO VARIATIONS IN ANTIGEN/ANTIBODY RATIO AND POSSIBLE ERRONEOUS TEST RESULTS. THE CUSTOMER INDICATED THAT THE INCORRECT DISPENSE OF FLUID WAS NOTICED IMMEDIATELY AND TESTING WAS NOT COMPLETED, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED. IF THIS INCIDENT WERE TO RECUR UNDETECTED, ERRONEOUS RESULTS COULD BE 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 *