BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2160274 · Received June 2, 2011

    Report

    Report Number
    1061932-2011-00535
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 2, 2009
    Report Date
    April 3, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ADDRESSES LH750 ANALYZER (1 OF 2) ON DAY 1 OF 2. SEE MDR #1061932-2011-00536 FOR LH750 ANALYZER (2 OF 2) ON DAY 2 OF 2. AN ANALYSIS OF THE RAW DATA ASSOCIATED WITH THIS PATIENT SAMPLE INDICATED A LARGE POPULATION OF CELLS NEXT TO THE MATURE RED BLOOD CELL (RBC) POPULATION. THIS SET OF CELLS NEXT TO THE RBCS APPEARS TO BE UNGHOSTED RBCS TO THE INSTRUMENT. THE SOFTWARE ALGORITHM FOR THE LH750 ANALYZER IS NOT SENSITIVE ENOUGH TO DIFFERENTIATE BETWEEN RETICULOCYTES AND UNGHOSTED RBCS IN THIS PATIENT'S SAMPLE. THIS SITUATION APPEARS TO BE A PATIENT-SPECIFIC ISSUE AND FIELD SERVICE WAS NOT DISPATCHED TO THE SITE AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2009, THE LH750 HEMATOLOGY ANALYZER GENERATED ERRONEOUSLY HIGH RETICULOCYTE RESULTS ON ONE PATIENT SAMPLE. OPERATOR-DEFINED MESSAGES (ABNORMAL HIGH AND RETICULOCYTOSIS) ACCOMPANIED THE TEST RESULTS. A MANUAL RETICULOCYTE COUNT WAS PERFORMED TWICE ON THE SAME PATIENT SAMPLE WITH SIGNIFICANTLY LOWER RESULTS. THE SAME SAMPLE WAS RUN ON THE LABORATORY'S DXH 800 HEMATOLOGY INSTRUMENT AND A COUNT SIMILAR THE MANUAL COUNT WAS GENERATED. THE CUSTOMER CONSIDERS THE MANUAL COUNT AND THE DXH 800 RESULTS TO BE CORRECT. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THERE WERE NO REPORTED CHANGES TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    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 UNK