BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2172118 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00602
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    June 17, 2009
    Report Date
    July 2, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ANALYZER 3 OF 3 ON DAY 2 OF 2. SEE MDR #1061932-2011-00600 FOR ANALYZER 1 OF 3 ON DAY 1 OF 2 AND MDR #1061932-2011-00601 FOR ANALYZER 2 OF 3 ON DAY 2 OF 2. TESTING REPORTED IN THIS SERIES OF MDRS WAS ON THE SAME SAMPLE FROM ONE PATIENT. IT WAS DETERMINED THAT THE FLAGGING PREFERENCES ON THE INSTRUMENT WERE SET AT MID-LEVEL SENSITIVITY FOR BLAST, VARIANT LYMPHOCYTE AND IMMATURE NEUTROPHIL 2, WITH IMMATURE NEUTROPHIL 1 DETECTION TURNED OFF. AN ANALYSIS OF THE RAW DATA ASSOCIATED WITH THIS SAMPLE SHOWS SLIGHTLY ABNORMAL MONOCYTE POPULATIONS; HOWEVER, THE ABNORMALITY WAS NOT SIGNIFICANT ENOUGH FOR THE COMPUTER ALGORITHM SET IN THE LH750 ANALYZER TO TRIGGER FLAGS FOR BLAST CELLS. THIS APPEARED TO BE A SAMPLE-SPECIFIC ISSUE AND FIELD SERVICE WAS NOT DISPATCHED TO THE SITE.

    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 SAMPLE FROM ONE PATIENT. BECAUSE OF A VERY LOW WBC (WHITE BLOOD CELL) COUNT OF 2.0 X 10^3 CELLS PER UL AND A REVIEW FLAG ON THE SAMPLE TEST RESULTS, THE CUSTOMER PROCEEDED TO PERFORM A MANUAL DIFFERENTIAL AND NOTED THE PRESENCE OF 9% BLAST CELLS. THE CUSTOMER BELIEVED THE RESULTS FROM THE MANUAL DIFFERENTIAL TO BE CORRECT. THE ERRONEOUS RESULTS WERE NOT 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