BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS IMPACT PIPETTOR

    MDR report key: 824542 · Received November 2, 2006

    Report

    Report Number
    1056600-2006-00233
    Event Type
    Malfunction
    Date Received
    November 2, 2006
    Date of Event
    December 8, 2004
    Report Date
    November 2, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DID NOT GENERATE ENOUGH INFORMATION TO DETERMINE A ROOT CAUSE. THE ISSUE WAS MITIGATED BY REPLACEMENT OF THE ORIGINAL PIPETTE. THE ORIGINAL PIPETTE WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMPACT PIPETTOR DID NOT DISPENSE CORRECTLY. IF THERE IS AN INCORRECT OR NO DISPENSE EVENT THAT GOES UNDETECTED, ERRONEOUS RESULTS COULD BE REPORTED. THERE WAS NO REPORT OF HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS IMPACT PIPETTOR DISPENSER GJG MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1