BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2363554 · Received December 8, 2011

    Report

    Report Number
    1061932-2011-02614
    Event Type
    Malfunction
    Date Received
    December 8, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED THE SAME DAY IN A 3ML EDTA TUBE. THE SPECIMEN WAS STORED AT ROOM TEMPERATURE. QC WAS RUN BEFORE THIS EVENT AND RECOVERED WITHIN ASSAY RANGES. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO ACCURACY AND PRECISION. THE DHX 800 SENSITIVITY SETTINGS ARE SET HIGH FOR VARIANT LY, IMMATURE GRANULOCYTES AND FOR LEFT SHIFT (DEFAULT SETTING IS HIGH FOR ALL DIFFERENTIAL PARAMETERS). RAW DATA ANALYSIS REVEALED: THE SAMPLE PROVIDED HAS 4-5% BLASTS ACCORDING TO THE MANUAL REFERENCE. THE ALGORITHM DID NOT SET ANY SUSPECT FLAGS. THE POPULATIONS LOOK NORMAL AND THE STATISTICS OF THEM ARE WITHIN NORMAL RANGE. THE LYMPHOCYTE AND MONOCYTE POPULATIONS OVERLAP EACH OTHER, BUT IT IS NOT SIGNIFICANT ENOUGH TO SET A BLAST FLAG. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE IS UNKNOWN: BASED ON RAW DATA ANALYSIS, THE PATIENT SPECIMEN WAS NOT SIGNIFICANTLY ABNORMAL TO TRIGGER INSTRUMENT BLAST FLAGGING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM DID NOT FLAG A PATIENT SPECIMEN FOR BLAST FLAG. . THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE PATHOLOGIST REVIEWED THE PATIENT SPECIMEN AND PERFORMED A MANUAL DIFFERENTIAL WERE HE DISCOVERED 4-5% BLAST CELLS ON THE SMEAR. DETAILS RESULTS FOR THE MANUAL DIFFERENTIAL WERE NOT PROVIDED. A CORRECTED REPORT WAS SENT OUT. PATIENT RESULTS ARE PROVIDED IN THIS REPORT. NO CHANGE TO PATIENT TREATMENT WAS ATTRIBUTED TO THIS EVENT. NO DEATH OR SERIOUS INJURY IS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR