BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2172133 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00598
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    June 24, 2009
    Report Date
    July 1, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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 ADDITIONAL REPORTABLE EVENTS. THIS MDR IS FOR DAY 1 OF 2. SEE MDR #1061932-2011-00599 FOR DAY 2 OF 2. SAMPLES FROM THE SAME PT WERE INVOLVED ON BOTH DAYS. AN ANALYSIS OF THE RAW DATA ASSOCIATED WITH THIS SAMPLE WAS NOT POSSIBLE BECAUSE THE NEEDED COMPUTER FILES WERE NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE IS UNK, THOUGH THE ERRONEOUS RESULTS APPEAR TO BE A SAMPLE-SPECIFIC ISSUE. SERVICE WAS NOT DISPATCHED TO THE SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LH750 HEMATOLOGY ANALYZER GENERATED AN ERRONEOUSLY NEGATIVE NRBC (NUCLEATED RED BLOOD CELL) RESULT ON ONE PT. THE ANALYZER REPORTED 0% NRBC. THE ERRONEOUS TEST RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED A MANUAL COUNT ON THIS SAMPLE AND RECORDED AN NRBC RESULT OF 19%. A CORRECTED REPORT WAS SUBSEQUENTLY ISSUED. 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 49 YR