BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3141192 · Received June 3, 2013

    Report

    Report Number
    1061932-2013-00940
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND FOUND A HOLE IN THE TUBING THROUGH PINCH VALVE PV35. THE FSE REPLACED THE TUBING AND NO FURTHER LEAKS WERE OBSERVED. THE FSE DISCOVERED THAT THE LEAK HAD DAMAGED THE PELTIER MODULE AND CAUSED THE INSTRUMENT TO GENERATED TEMPERATURE ERRORS. THE FSE PROCEEDED TO REPLACE THE PELTIER MODULE TO RESOLVE THE TEMPERATURE ERRORS AND REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A HOLE IN THE TUBING THROUGH PINCH VALVE PV35 AND FAILURE MODE OF THE TEMPERATURE ERRORS IS ATTRIBUTED TO A DAMAGED PELTIER MODULE. THE INSTRUMENT OPERATED AS INTENDED BY GENERATING TEMPERATURE ERRORS TO ALERT THE OPERATOR TO AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF APPROXIMATELY 5 ML INSIDE THE LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND THE INSTRUMENT GENERATED TEMPERATURE ERRORS WHEN THE LEAK WAS NOTICED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO DISCREPANT PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243025 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1