BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2950555 · Received February 8, 2013

    Report

    Report Number
    1061932-2013-00131
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: BECKMAN COULTER COLLECTED RAW DATA FROM THE CUSTOMER FOR ANALYSIS. THE RESULTS OF RAW DATA ANALYSIS ARE NOT AVAILABLE YET. THE SAMPLE WAS PREVIOUSLY TESTED ON ANOTHER DXH 800 INSTRUMENT AND SIMILAR RESULTS WITHOUT BLAST FLAG WERE OBTAINED. THE EVENT ON THAT INSTRUMENT IS DOCUMENTED IN MDR #1061932-2013-00130.

    Additional Manufacturer Narrative · 1

    THE RAW DATA WAS COLLECTED FROM THE CUSTOMER'S OTHER INSTRUMENT THAT GENERATED SIMILAR RESULTS ON THE PATIENT SAMPLE. THE RAW DATA ANALYSIS CONDUCTED BY BECKMAN COULTER INDICATED THAT THE LYMPHOCYTE AND MONOCYTE POPULATIONS IN THE PATIENT SAMPLE WERE OVERLAPPING EACH OTHER. HOWEVER, THE FLAGGING RULES WERE NOT SENSITIVE ENOUGH TO SET THE BLAST FLAG. THE RELATED EVENT ON THE CUSTOMER'S OTHER DXH INSTRUMENT IS DOCUMENTED IN MDR #1061932-2013-00130.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM DID NOT GENERATE BLAST FLAG FOR ONE PATIENT WHO HAD 23% BLASTS IDENTIFIED BY MANUAL SMEAR REVIEW. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, BUT THE IMPACT TO PATIENT TREATMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54617 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR