BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2210145 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01065
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    February 26, 2010
    Report Date
    March 2, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN ONCE PER DAY AND WERE ACCEPTABLE THE DAY OF THE SAMPLE RUN AND THE NEXT. THE UNIT WAS PERFORMING WITH SPECIFICATIONS. ON 03/03/2010, THE FIELD SERVICE ENGINEER REPLACED THE MIXING CHAMBER AND ALL ASSOCIATED TUBING AND OPTIMIZED THE E LYSE AND S LYSE PUMPS. RAW DATA ANALYSIS WAS CONDUCTED. THE SAMPLE HAS IMMATURE CELLS AND NRBCS, WITH NO SUSPECT FLAGS. THE HISTOGRAM PATTERN LOOKED SLIGHTLY ABNORMAL, BUT IT WAS NOT SIGNIFICANT ENOUGH TO SET IMMATURE CELL FLAGS. THE WBC HISTOGRAM FROM COMPLETE BLOOD COUNT (CBC) ALSO LOOKS NORMAL, THUS THE NRBC FLAG WAS NOT SET. ROOT CAUSE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS HIGH WHITE BLOOD CELL (WBC) COUNT AND DIFFERENTIAL TEST RESULTS WERE OBTAINED FOR ONE PT SAMPLE WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. THERE WERE NO INSTRUMENT GENERATED FLAGS WITH THE TEST RESULTS. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. THE PHYSICIAN QUESTIONED THE RESULTS, AS THESE RESULTS WERE DISCORDANT WHEN COMPARED TO TEST RESULTS OBTAINED FOR A BONE MARROW ASPIRATE PERFORMED PRIOR. A MANUAL DIFFERENTIAL WAS PERFORMED WITH NUCLEATED RED BLOOD CELLS (NRBC) AND IMMATURE WHITE BLOOD CELLS IDENTIFIED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK