BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ID TIPMASTER PIPETTOR

    MDR report key: 781534 · Received November 10, 2006

    Report

    Report Number
    1056600-2006-00280
    Event Type
    Malfunction
    Date Received
    November 10, 2006
    Date of Event
    May 20, 2006
    Report Date
    November 10, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REMOVED THE PIPETTOR FROM SERVICE AND PERFORMED MAINTENANCE USING THE TIPMASTER MAINTENANCE KIT. CLEANING, RE-GREASING AND HANGING THE O-RINGS BROUGHT THE DEVICE BACK TO EXPECTED OPERATION. THOUGH THE MOST LIKELY ROOT CAUSE OF THE EVENT IS USER ERROR IN MAINTAINING THE PIPETTOR, THE POSSIBILITY OF PIPETTE MALFUNCTION COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE PIPETTOR WAS LEAKING. THIS COULD RESULT IN VARIABLE DELIVERY OF REAGENTS. DISPENSING VARIABLE VOLUMES OF REAGENTS/SAMPLES COULD CAUSE ERRONEOUS TEST RESULTS. THERE WAS NO REPORT OF PATIENT 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