BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 1891693 · Received November 5, 2010

    Report

    Report Number
    1061932-2010-00204
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 3, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A 4ML EDTA VACUTAINER TUBE, STORED AT ROOM TEMPERATURE, AND SAMPLED WITHIN 4 HOURS OF COLLECTION. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN BEFORE AND AFTER THIS EVENT AND RECOVERED WITHIN ASSAY LIMITS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE FOR THE DXH 800 INSTRUMENT NOT FLAGGING THE SPECIMEN DIFFERENTIAL IS THAT THE SAMPLE WAS NOT SIGNIFICANTLY ABNORMAL ENOUGH TO SET A VARIANT LYMPH FLAG.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM NOT GENERATING A FLAG FOR ATYPICAL LYMPH CELLS ON A PATIENT SPECIMEN. THE OPERATOR DECIDED TO RANDOMLY PERFORM A MANUAL DIFFERENTIAL AND NOTICED A LARGE NUMBER OF ATYPICAL LYMPH CELLS PRESENT. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, BUT A CORRECTED REPORT WAS ISSUED. NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1