BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2172123 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00594
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    June 17, 2009
    Report Date
    June 19, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. AN ANALYSIS OF THE RAW DATA ASSOCIATED WITH THIS PT SAMPLE WAS CONDUCTED. ALTHOUGH INTERFERENCE MATERIAL WAS SEEN IN THE WBC HISTOGRAM, ACCORDING TO LH750 SOFTWARE ALGORITHM DESIGN, THE WBC HISTOGRAM IN THIS SPECIFIC CASE HAD A LOWER NUMBER OF INTERFERENCE EVENTS THAN THAT REQUIRED TO TRIP A CELLULAR INTERFERENCE FLAG ON THE WBC RESULTS REPORT. FURTHER, THE HISTOGRAM DID NOT FORM A SIGNIFICANT PATTERN ON WHICH TO PERFORM A HISTOGRAM SUBPOPULATION ANALYSIS THAT WOULD IDENTIFY CELLULAR INTERFERENCE. 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 GENERATED AN ERRONEOUS WBC (WHITE BLOOD CELL) COUNT OF 500 CELLS/ CU MM FROM A SPINAL FLUID SAMPLE FROM ONE PT. THE PT SAMPLE WAS PRE-TREATED WITH HYALURONIDASE BEFORE PROCESSING ON THE ANALYZER. THE CUSTOMER PERFORMED A MANUAL WBC COUNT ON THE SAMPLE AND SAW 10 CELLS/ CU MM. DURING THIS EXAMINATION THE CUSTOMER REPORTED SEEING MANY YEAST CELLS WHICH THEY BELIEVE TO BE THE INTERFERING SUBSTANCE. THE ERRONEOUS TEST RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WERE NO REPORTED CHANGES TO PT 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