BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2183624 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00659
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    December 11, 2008
    Report Date
    December 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. SENSITIVITY FOR FLAGGING WAS SENT TO [2222], WHICH IS MID-LEVEL SETTING FOR BLASTS AND VARIANT LY, IMM NE 1 AND IMM NE 2. 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. THE ANALYZER WAS NOT EVALUATED. RAW DATA ANALYSIS WAS PERFORMED AND DETERMINED THAT AN INSTRUMENT FAILURE WAS A POTENTIAL CAUSE FOR THE ERRONEOUS RESULTS GENERATED. THE ROOT CAUSE IS UNKNOWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6), 2008 AND (B)(6), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL RESULTS WITH A SPECIFIC PT SAMPLE WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE DIFFERENTIAL RESULTS WERE DETERMINED TO BE ERRONEOUS BASED ON RERUN ON THE SAME ANALYZER AND MANUAL BLOOD SMEAR DIFFERENTIAL. THE ERRONEOUS DIFFERENTIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. 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 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR