BEUDAMED
    FDA Adverse Event Other Summary report: N

    MTS PIPETTE

    MDR report key: 897127 · Received August 15, 2007

    Report

    Report Number
    9681721-2007-00012
    Event Type
    Other
    Date Received
    August 15, 2007
    Date of Event
    June 15, 2007
    Report Date
    August 15, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF MANUFACTURE COULD NOT BE CONFIRMED AT THIS TIME. 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 NOT CONFIRMED AT THE DEPOT. ISSUE RESOLVED THROUGH PRODUCT REPLACEMENT. THE PIPETTOR IN QUESTION WILL BE STAGED FOR DISPOSITION. PROBLEMS OF THIS NATURE CAN TYPICALLY BE RESOLVED AT THE MANUFACTURER US REPAIR FACILITY.

    Description of Event or Problem · 1

    THE KEYBOARD IS STICKING WHICH CAUSES CHANGES IN THE VOLUME TO OCCUR WHILE PIPETTING. THE CUSTOMER REPEATED TESTING USING AN ALTERNATE PIPETTOR AND REPORTED THAT RESULTS WERE ACCEPTABLE ISSUE WAS RESOLVED THROUGH PRODUCT REPLACEMENT.

    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