BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2841006 · Received November 20, 2012

    Report

    Report Number
    1061932-2012-02746
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER-SUPPLIED RAW DATA ANALYSIS INDICATES THE LYMPHOCYTE POPULATION IS OVERLAPPING THE MONOCYTE POPULATION. THE PERCENTAGE OF THE MONOCYTES REPORTED BY THE ALGORITHM IS SLIGHTLY HIGHER THAN NORMAL BUT NOT ABNORMAL ENOUGH TO TRIGGER THE BLAST FLAGGING RULES.

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE PATIENT SAMPLE WAS COLLECTED IN A 5 ML VACUTAINER TUBE. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED FALSE NEGATIVE BLAST CELLS, FOR ONE PATIENT, INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER MEASURED THE SAMPLE WITH FLOW CYTOMETRY AND OBSERVED 13.9% OF BLAST CELLS, WHICH WAS CONSIDERED CORRECT. THE MANUAL RESULTS WERE 32% SEGMENTS, 54% LYMPHOCYTES, AND 3% MONOCYTES. ELEVEN PERCENT (11%) OF LARGE CELLS WAS BETWEEN LYMPHOCYTE AND MONOCYTE, WITH AN IMMATURE NUCLEAR STRUCTURE. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE INSTRUMENT HAS BEEN PERFORMING WITHIN QUALITY CONTROL (QC) SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1