BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2171242 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00673
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 24, 2009
    Report Date
    July 10, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. AN ANALYSIS OF THE RAW DATA FROM THIS TEST RESULT WAS CONDUCTED. THE SAMPLE DEMONSTRATED AN ABNORMAL NEUTROPHIL POPULATION, WITH MANY NEUTROPHIL EVENTS APPEARING IN THE MONOCYTE REGION OF THE HISTOGRAM. THE SOFTWARE ALGORITHM FOR THE LH750 ANALYZER WOULD HAVE GENERATED AN IMM NE1 (IMMATURE BAND CELL) FLAG; HOWEVER, IT WOULD NOT HAVE BEEN SENSITIVE ENOUGH TO SET A BLAST FLAG FOR THIS SAMPLE. FURTHER, THE IMM NE1 FEATURE WAS TURNED OFF ON THIS ANALYZER. FLAGGING PREFERENCES WERE SET TO HIGHEST SENSITIVITY LEVEL FOR BLAST CELLS, MID-LEVEL FOR VARIANT LYMPHOCYTES AND IMM NE 2 (FOR IMMATURE NEUTROPHIL) WITH IMM NE 1 TURNED OFF. IN SUMMARY, THE SOFTWARE ALGORITHM WAS NOT SENSITIVE ENOUGH TO INITIATE A BLAST FLAG FOR THIS SAMPLE. 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 FAILED TO FLAG FOR THE PRESENCE OF BLAST CELLS IN A BLOOD SPECIMEN FROM ONE PATIENT. THE ERRONEOUS TEST RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER PERFORMED A MANUAL DIFFERENTIAL ON THE SAMPLE AND NOTED 30% BLAST CELLS. THE CUSTOMER BELIEVED THE MANUAL DIFFERENTIAL RESULTS TO BE CORRECT. A CORRECTED REPORT WAS SUBSEQUENTLY ISSUED. 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 UNK