BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ID TIPMASTER PIPETTOR

    MDR report key: 781369 · Received November 10, 2006

    Report

    Report Number
    1056600-2006-00278
    Event Type
    Malfunction
    Date Received
    November 10, 2006
    Date of Event
    January 24, 2005
    Report Date
    November 10, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT CONFIRMED THAT THE PIPETTOR WAS NOT PERFORMING AS EXPECTED. THE DEVICE WAS RETURNED TO OCD AND A REPLACEMENT SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED THAT THE PIPETTOR WAS NOT ASPIRATING PROPERLY. DISPENSING VARIABLE VOLUMES OF REAGENTS/SAMPLES COULD CAUSE ERRONEOUS TEST RESULTS. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ID TIPMASTER PIPETTOR MANUAL PIPETTOR GJG MICRO TYPING SYSTEMS, INC. MTS9640 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *