BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2589380 · Received May 25, 2012

    Report

    Report Number
    1061932-2012-01685
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    April 30, 2012
    Report Date
    April 30, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE BELT ON THE COULTER LH 750 HEMATOLOGY ANALYZER (LH 750) WAS NOT ADVANCING ALL OF THE TIME. CUSTOMER REPORTED THAT THE LH 750 WAS GIVING DIFFERENTIAL DEBRIS ON THE SCATTER PLOT AND AN INCREASING NUMBER OF INCOMPLETE DIFFERENTIAL RESULTS. CUSTOMER REPORTED THERE WAS A LEAK FROM THE LH 750. CUSTOMER REPORTED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. CUSTOMER REPORTED THAT THE VOLUME OF THE LEAK WAS 20 ML. 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 SOURCE OF THE LEAK WAS THE BENT SECONDARY MANUAL PROBE. THE FSE COULD NOT REPRODUCE THE ISSUE OF THE BELT NOT ADVANCING INTERMITTENTLY. THE FSE PERFORMED PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1