BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2147287 · Received May 26, 2011

    Report

    Report Number
    1061932-2011-00371
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 14, 2008
    Report Date
    May 16, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FLAGGING PREFERENCES ARE SET TO '2202'. THIS MID-LEVEL FOR BLAST, VARIANT LYMPH, AND IMM NE 2; IMM NE 1 IS SET TO OFF. ON (B)(6) 2008, THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE LATRON DIFFERENTIAL SCATTER WAS RUNNING LOW AND THE RETICULOCYTE SCATTER IS RUNNING HIGH, THE COUNT TIMES ARE SLIGHTLY FAST AND THE SHEAR VALVES HAD EXCESSIVE BUILDUP. THE FSE REPLACED THE WHITE BLOOD CELL (WBC) DISPENSER AND CLEANED THE APERTURES. THE FSE ADJUSTED THE LATRON PARAMETERS TO ASSIGNED ASSAY VALUES, DECREASED SAMPLE PRESSURES TO INCREASE COUNT TIMES, AND CLEANED THE BLOOD SAMPLING AND SHEAR VALVES. INSTRUMENT WAS VERIFIED PER ESTABLISHED PROCEDURES. DATA FILES WERE EVALUATED. ALL FILES SHOWED NEUTROPHIL POPULATIONS WITH TAILS. THE ALGORITHM IN THE LH750 SOFTWARE IS DESIGNED TO FLAG IF A TAIL IS SIGNIFICANT ENOUGH. THE DATAFILE OF THE SAMPLE RAN ON (B)(6) 2008 HAS NO IMM NE 2 FLAG, BECAUSE IT HAS A SLIGHTLY LESS SIGNIFICANT TAIL. LH750 SOFTWARE ALGORITHM DID GENERATE AN IMM NE 1 FLAG (AT ALL SENSITIVITY LEVELS) AND AN IMM NE 2 FLAG (AT HIGH SENSITIVITY LEVEL ONLY). HOWEVER, THE FLAGS WERE NOT PRINTED DUE TO THE SENSITIVITY SETTINGS ON THE INSTRUMENT. THERE WAS NO DEFINITIVE ROOT CAUSE IDENTIFIED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FAILURE OF THE COULTER LH 750 HEMATOLOGY ANALYZER TO FLAG THE PRESENCE OF BLAST CELLS IN THE COMPLETE BLOOD COUNT (CBC) RESULTS FOR ONE PATIENT ON (B)(6) 2008. ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LAB FOR THIS SAMPLE. MANUAL DIFFERENTIAL FOUND 2% BLASTS. A CORRECTED REPORT WAS ISSUED. THERE WAS NO DEATH, SERIOUS INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH 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