BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2210116 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01086
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    February 24, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS INCIDENT. ANALYSIS OF THE ALGORITHM INDICATED WBC VOTING LOGIC STATES THAT THERE WILL BE NO VOTING PERFORMED IF THE AVERAGE OF ALL THREE APERTURES IS BELOW A DEFINED THRESHOLD OF AROUND 0.7. ROOT CAUSE FOR THE ERRONEOUS WBC COUNT IS THE WBC VOTING LOGIC DOES NOT PERFORM VOTING BELOW THRESHOLD. AN APERTURE WAS PLUGGED WITH ESSENTIALLY 0 COUNTS AND THE INSTRUMENT FAILED TO VOTEOUT THE LOW COUNT AND AVERAGED ALL 3 APERTURES. IN THIS SITUATION THE INSTRUMENT AVERAGES ALL 3 APERTURES INCLUDING THE NEARLY 0 AND THEREFORE THE AVERAGE COUNTS ARE ERRONEOUSLY LOW. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW WHITE BLOOD CELL (WBC) COUNT WAS OBTAINED FOR A BODY FLUID SAMPLE FOR ONE PT WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THERE WERE NO INSTRUMENT GENERATED FLAGS ON THE PRINTOUT OR WORKSTATION SCREEN. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK