BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2160278 · Received June 2, 2011

    Report

    Report Number
    1061932-2011-00540
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    August 28, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A VACUTAINER AND WAS SAMPLED LESS THAN EIGHT HOURS LATER. THE INSTRUMENT WAS PERFORMING WITHIN QUALITY CONTROL (QC) SPECIFICATIONS. CONTROLS WERE RUN ON EVERY SHIFT. FLAGGING PREFERENCES WERE SET TO 3302, WHICH IS HIGH LEVEL FOR BLAST AND VARIANT LYMPH FLAGGING, MID- LEVEL FOR IMM NE 2, AND IMM NE 1 IS SET TO OFF. (IMM NE 2 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY METAMYELOCYTES, MYELOCYTES, AND PROMYELOCYTES; IMM ME 1 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY BANDS.) SERVICE WAS NOT DISPATCHED FOR THIS EVENT. REVIEW OF THE RAW DATA FOUND THAT THE ABNORMALITIES WERE NOT SIGNIFICANT ENOUGH FOR THE ALGORITHM TO SET SUSPECT FLAGS. ROOT CAUSE CAN BE ATTRIBUTED TO THE LYMPHOCYTES AND NEUTROPHIL HISTOGRAMS OF THE SAMPLES LOOKING NORMAL AND SHOWING NO INDICATIONS OF ABNORMALITY. THE ABNORMALITIES OF THE MONOCYTE POPULATION WERE NOT SIGNIFICANT ENOUGH FOR THE ALGORITHM TO SET SUSPECT FLAGS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00545.

    Description of Event or Problem · 1

    ON (B)(6) 2008, CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL RESULTS WITH NO INSTRUMENT GENERATED ERROR MESSAGES WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER. SAMPLE TESTED ON (B)(6) 2008 DEMONSTRATED 8% BLASTS ON ONE MANUAL BLOOD SMEAR DIFFERENTIAL, AND 12% BLASTS ON ANOTHER MANUAL BLOOD SMEAR DIFFERENTIAL. THERE WERE NO BLAST FLAGS GENERATED FOR THE AUTOMATED DIFFERENTIAL. THE ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 2 OF 2 EVENTS REPORTED BY THIS CUSTOMER.

    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 59 YR