BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2172151 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00590
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    November 7, 2008
    Report Date
    November 13, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA ANALYSIS WAS CONDUCTED. RAW DATA ANALYSIS DEMONSTRATED THE FOLLOWING SAMPLE SPECIFIC INFORMATION: IN THIS SPECIFIC SAMPLE, THE NRBC CELLS AND LYMPHOCYTE CELLS SHOWED UP AS ONE MERGED POPULATION IN BOTH WBC DIFFERENTIAL SCATTER PLOTS AND WBC HISTOGRAM. BECAUSE OF THE SPECIAL CHARACTERISTICS OF THE SAMPLE DATA PATTERN, ALGORITHM FAILED TO GATE A HIGH PERCENTAGE OF NRBC CELLS FOR THIS SAMPLE. MULTIPLE WBC DIFFERENTIAL FLAGS WERE GENERATED BY THE INSTRUMENT (SUCH AS BLAST, IMM NE 2 AND/OR VERIFY DIFF) FOR EACH TEST. RETICULOCYTE INSTRUMENT GENERATED FLAGS WERE GENERATED ON EACH SAMPLE RUN TO PROMPT THE CUSTOMER TO FURTHER REVIEW THE RETICULOCYTE RESULTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00591.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS WHITE BLOOD CELL (WBC), RETICULOCYTE, AND NUCLEATED RED BLOOD CELL (NRBC) TEST RESULTS WHEN USING A COULTER LH 780 HEMATOLOGY ANALYZER. THERE WERE INSTRUMENT GENERATED FLAGS ASSOCIATED WITH THE TEST RESULTS. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. PHYSICIAN QUESTIONED THE RESULTS AND A SECOND SAMPLE WAS OBTAINED FROM THE PT. MANUAL DIFFERENTIAL WAS PERFORMED AND A CORRECTED REPORT WAS ISSUED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 1 OF 2 EVENTS REPORTED BY THIS CUSTOMER. THIS MDR IS FOR THE FIRST OF TWO LH780 ANALYZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 780 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO