BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS PIPETTE

    MDR report key: 855013 · Received May 24, 2007

    Report

    Report Number
    9681721-2007-00008
    Event Type
    Malfunction
    Date Received
    May 24, 2007
    Date of Event
    March 13, 2007
    Report Date
    May 24, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 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 RATION AND ERRONEOUS TEST RESULTS. THE CUSTOMER COMPLAINT WAS CONFIRMED. ISSUE RESOLVED THROUGH PRODUCT REPLACEMENT. THE PIPETTOR IN QUESTION WILL BE STAGED FOR FUTURE DISPOSITION.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT THIS PIPETTE DISPENSED AN INCORRECT AMOUNT OF FLUID DURING PT TESTING.

    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