BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2171223 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00642
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 21, 2009
    Report Date
    May 8, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR IS FOR DAY 1 OF 2. SEE MDR # 1061932-2011-00643 FOR DAY 2 OF 2. AN ANALYSIS OF THE RAW DATA ASSOCIATED WITH THIS SAMPLE WAS CONDUCTED. BECAUSE THE NRBC (NUCLEATED RED BLOOD CELL) FLAG IS DERIVED FROM FEATURES ON BOTH THE WBC (WHITE BLOOD CELL) HISTOGRAM AND THE DIFFERENTIAL SCATTER PLOT, THE ANALYZER EVALUATES THOSE DATA IN ORDER FOR A FLAG TO BE GENERATED BY THE SOFTWARE ALGORITHM. IN THIS CASE THERE WAS NO NRBC FLAG BECAUSE THE WBC HISTOGRAM HAS NO OBVIOUS FEATURE TO INDICATE THE NRBC EVEN THOUGH THE DIFFERENTIAL SCATTER PLOT SHOWS A CERTAIN NUMBER OF EVENTS IN THE DEBRIS/ NRBC REGION. A FIELD SERVICE ENGINEER WAS NOT DISPATCHED TO THE SITE AS THIS APPEARED TO BE A SAMPLE-SPECIFIC ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LH750 HEMATOLOGY ANALYZER GENERATED ERRONEOUS NRBC (NUCLEATED RED BLOOD CELL) RESULTS ON ONE PATIENT. THE ANALYZER INDICATED THERE WERE NO NRBCS IN THE PATIENT SAMPLE AND THERE WERE NO FLAGS GENERATED FOR THE PRESENCE OF NRBCS. THE TEST RESULTS WERE, HOWEVER, ACCOMPANIED BY ANOTHER INSTRUMENT GENERATED MESSAGES. THE ERRONEOUS TEST RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER CONDUCTED A MANUAL EXAMINATION OF THE BLOOD SAMPLE AND NOTED A COUNT OF 10 NRBC PER 100 WBC (WHITE BLOOD CELLS). THE CUSTOMER INDICATED THAT THE NUCLEI OF THIS PATIENT'S NRBCS APPEARED TO BE TYPICALLY SMALLER THAN LYMPHOCYTES. THE CUSTOMER BELIEVED THAT THE MANUAL COUNT WAS THE CORRECT OBSERVATION. THERE WERE NO REPORTED CHANGES TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR