BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS PIPETTE

    MDR report key: 891180 · Received August 9, 2007

    Report

    Report Number
    9681721-2007-00011
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    June 12, 2007
    Report Date
    July 31, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    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 COMPLAINT WAS CONFIRMED. ISSUE RESOLVED THROUGH PRODUCT REPLACEMENT. THE PIPETTOR IN QUESTION WILL BE STAGED FOR FURTHER DISPOSITION.

    Description of Event or Problem · 1

    CUSTOMER IMMEDIATELY STOPPED USING THE MTS DEVICE WHEN THEY OBSERVED THE DISPENSE TO BE OF A LOWER VOLUME THAN INTENDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR