BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2300207 · Received October 19, 2011

    Report

    Report Number
    1061932-2011-01836
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Date of Event
    September 13, 2011
    Report Date
    September 19, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A FRESH 5ML EDTA TUBE. QC IS RUN EVERY EIGHT (8) HOURS AND WAS RUN BEFORE AND AFTER THIS EVENT AND RECOVERED WITHIN ASSAY RANGES. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO ACCURACY AND PRECISION. PREVIOUSLY RUN SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE CONTROL RUN. 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 PROVIDED SAMPLE HAS 17% BLASTS, BUT THE ALGORITHM DID NOT SET A BLAST SUSPECT FLAG FOR THE FIRST RUN. BOTH RUNS SHOW ELONGATED MONOCYTE POPULATIONS ON THE HISTOGRAMS. THE SECOND ONE DISPLAYS A SLIGHTLY MORE ABNORMAL PATTERN THAN THE FIRST ONE. THEREFORE, THE ALGORITHM SET BOTH BLAST AND IMMATURE GRAN FLAGS FOR THE SECOND RUN, BUT NO FLAGS FOR THE FIRST RUN. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE IS UNKNOWN: BASED ON RAW DATA ANALYSIS, THE SPECIMEN WAS ABNORMAL BUT NOT ENOUGH FOR THE ALGORITHM TO FLAG THE SPECIMEN. BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER SUGGESTS USING ALL AVAILABLE OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS DIFFERENTIAL RESULTS, AND DID NOT FLAG A PATIENT SPECIMEN FOR BLAST FLAG. THE CUSTOMER PERFORMED A MANUAL DIFFERENTIAL BECAUSE OF THE DEFINITIVE FLAG DISCOVERED 17% CELLS ON THE SMEAR. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. A CORRECTED REPORT WAS SENT OUT. 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 69 YR