BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS PIPETTE

    MDR report key: 897048 · Received August 15, 2007

    Report

    Report Number
    9681721-2007-00013
    Event Type
    Malfunction
    Date Received
    August 15, 2007
    Date of Event
    June 15, 2007
    Report Date
    August 15, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE BIOHIT PIPETTOR DISPENSED THE INCORRECT AMOUNT OF FLUID. NO DEFINITIVE ROOT CAUSE WAS DETERMINED. THE CUSTOMER OBSERVED THE ISSUE WHILE PIPETTING SAMPLE AND ABORTED TESTING, PREVENTING ERRONEOUS TEST RESULTS FROM BEING REPORTED. HOWEVER, IF THIS INCIDENT WERE TO OCCUR UNDETECTED, AN INCORRECT DISPENSE OF FLUID COULD LEAD TO VARIATION IN ANTIGEN/ANTIBODY RATIO AND ERRONEOUS TEST RESULTS. THE CUSTOMER'S COMPLAINT WAS CONFIRMED AT THE DEPOT. ISSUE RESOLVED THROUGH PRODUCT REPLACEMENT. THE PIPETTOR IN QUESTION WILL BE STAGED FOR FUTURE DISPOSITION.

    Description of Event or Problem · 1

    CUSTOMER REPORTING BIOHIT PIPETTOR CHANGES SETTINGS WHILE IN USE. THIS LEADS TO INCORRECT DISPENSING OF THE VOLUME INTENDED. KEYBOARD WAS ALSO NOTED AS STICKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS PIPETTE ELECTRONIC PIPETTOR JTC BIOHIT OYJ 710142MT N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR