BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2160272 · Received June 2, 2011

    Report

    Report Number
    1061932-2011-00547
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 21, 2009
    Report Date
    April 30, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 TEST DATA ASSOCIATED WITH THIS PATIENT SAMPLE INDICATED AN ABNORMAL MONOCYTE POPULATION WAS PRESENT; HOWEVER, THE SOFTWARE ALGORITHM OF THE LH750 ANALYZER WAS NOT SENSITIVE ENOUGH TO THIS PATTERN IN ORDER FOR THE INSTRUMENT TO GENERATE FLAGS FOR MONOCYTE BLAST CELLS. THIS APPEARS 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 ON (B)(6) 2009, THE LH750 HEMATOLOGY ANALYZER DID NOT FLAG A SAMPLE FROM ONE PATIENT FOR MONOCYTE BLAST CELLS. THE CUSTOMER PERFORMED A MANUAL DIFFERENTIAL ON THE SAMPLE AND 10% MONOCYTE BLAST CELLS WERE OBSERVED. THERE WERE NO ERRONEOUS RESULTS REPORTED OUTSIDE 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