BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2188363 · Received July 29, 2011

    Report

    Report Number
    1061932-2011-01011
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    January 28, 2010
    Report Date
    January 28, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS. CONTROLS WERE RUN THREE TIMES PER DAY. FLAGGING PREFERENCES WERE SET TO '2222' WHICH IS MID-LEVEL FOR BLAST CELLS. VARIANT LYMPHOCYTES, IMM NE 1 AND IMM NE 2 FLAGGING. NOTE: IMM NE 1 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY BANDS. IMM NE 2 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY METAMYELOCYTES, MYELOCYTES, AND PROMYELOCYTES. RAW DATA ANALYSIS WAS PERFORMED. REVIEW OF THE RAW DATA PROVIDED THAT THE SAMPLE SHOWED NO DISTINCTIVE ABNORMAL PATTERNS. THE ALGORITHM COULD NOT SET ANY SUSPECT FLAGS BECAUSE THE SAMPLE LOOKS NORMAL. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL TEST RESULTS WERE OBTAINED WHEN USING A COULTER LH 780 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO A MANUAL DIFFERENTIAL WITH 6% BLAST CELLS. THERE WERE NO INSTRUMENT GENERATED FLAGS WITH THE TEST RESULTS. ERRONEOUS 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 780 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR