BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2798279 · Received October 22, 2012

    Report

    Report Number
    1061932-2012-02573
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A CLEAR, OPEN MODE PROBE WIPE LEAK OUTSIDE THE COULTER LH 500 HEMATOLOGY ANALYZER. CUSTOMER REPORTED THE LEAK SPILLED ON THE TABLETOP. CUSTOMER REPORTED THAT THE VOLUME OF THE LEAK WAS APPROXIMATELY 5 CUBIC CENTIMETERS. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE PROBE WAS LEAKING. THE FSE FOUND THAT THE PROBE WIPE ASSEMBLY WAS NOT FULLY RETRACTING. THE FSE REPLACED THE BALL BEARING SLIDE AND THE PROBE WIPE ASSEMBLY TO REGAIN FULL MOTION. THE INSTRUMENT RAN WITHOUT ANY LEAKS AFTER THE REPAIRS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1