BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALZYER

    MDR report key: 2211710 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01106
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    October 19, 2009
    Report Date
    October 19, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. A SOFTWARE ENGINEER AT BECKMAN COULTER REVIEWED THE INFO THAT WAS PROVIDED BY THE CUSTOMER AND CONCLUDED THAT IN ORDER FOR SAMPLES TO BE SAVED IN THE CONTROL FILE, AS DESCRIBED BY THE CUSTOMER, THE PROCESS TYPE OF THE LH750 ANALYZER WOULD NEED TO BE SET TO "CONTROL". THE SOFTWARE USES THE PROCESS TYPE TO DETERMINE WHERE TO STORE THE SAMPLE RESULTS AND IF IT IS SET TO CONTROL, THEN IT USES THE DEFAULT CONTROL LOT AS THE FILE IN WHICH TO STORE THE RESULTS. THIS SCENARIO OF RUNNING BAR CODE READ VERSUS BARCODE NO READS WITH PROCESS TYPE SET TO CONTROL WAS VERIFIED ON AN INSTRUMENT IN-HOUSE WITH THE SAME OUTCOME AS INDICATED ABOVE WITH RESULTS FROM NO READ BARCODE TUBES SENT TO THE DEFAULT CONTROL FILE. THE CUSTOMER HAD INDICATED, HOWEVER, THAT THE PROCESS TYPE WAS SENT TO AUTO ANALYSIS, NOT CONTROL. ON (B)(6) 2009, A FIELD SERVICE ENGINEER VISITED THE SITE TO EVALUATE THE INSTRUMENT. HE CONFIRMED THE ANALYZER WAS SET WITH CHECKSUM ENABLE. HE REPLACED THE BARCODE SCANNER AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES WITH RESULTS MEETING PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH PARTS WERE REPLACED AND AN ALTERNATE SCENARIO COULD REPRODUCE THE PROBLEM, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LH750 HEMATOLOGY ANALYZER MIS-IDENTIFIED FOUR UNIQUE PT SAMPLES AS DAILY QUALITY CONTROL (QC) SAMPLES. THE SAMPLES WERE RUN IN DIFFERENT CASSETTES IN FOUR DIFFERENT POSITIONS. THE BAR CODE LABEL ON EACH OF THE FOUR SAMPLES WAS NOT READ, GENERATING A NO READ CONDITION WITH TEST RESULTS SENT TO THE PT CONTROL FILE BY DEFAULT. THE CUSTOMER DISCOVERED THE ISSUE WHEN PT RESULTS WERE POSTED TO THE DAILY PT QC FILE AND THE RESULTS FROM THE FOUR PT SAMPLES WERE NOT PRINTED OUT AS PT SAMPLES. THERE WERE NO ERRONEOUS OR MIS-IDENTIFIED RESULTS REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NOT REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH750 HEMATOLOGY ANALZYER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK