BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ID TIPMASTER PIPETTOR

    MDR report key: 821303 · Received January 26, 2007

    Report

    Report Number
    1056600-2007-00022
    Event Type
    Malfunction
    Date Received
    January 26, 2007
    Date of Event
    December 28, 2006
    Report Date
    January 26, 2007
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PIPETTOR. THE INSTRUMENT WAS RETURNED TO OCD DEPOT FOR EVALUATION. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE KNOB THAT CONTROLS THE VOLUME SETTINGS ON THE MTS ID TIPMASTER PIPETTOR WAS DAMAGED. A DAMAGED VOLUME KNOB COULD LEAD TO INCORRECT DISPENSE OF FLUID WHICH MAY LEAD TO VARIATIONS IN ANTIGEN / ANTIBODY RATIO AND POSSIBLE ERRONEOUS TEST RESULTS. THE CUSTOMER INDICATED THAT TESTING WAS NOT BEING PERFORMED AT THE TIME OF THE INCIDENT. 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 *