BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3143597 · Received June 3, 2013

    Report

    Report Number
    1061932-2013-01045
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER THE INSTRUCTIONS FOR USE (IFU), THE DXH 800 CALCULATES THE WBC RESULT USING THE COULTER PRINCIPLE FOR WHITE BLOOD CELL COUNT OR LEUKOCYTE COUNT. THE WBC IS CORRECTED FOR INTERFERENCE IF NECESSARY. IF NO CORRECTION IS REQUIRED, THEN THE WBC=UWBC. THE UWBC (UNCORRECTED WBC) IS MEASURED DIRECTLY AND MULTIPLIED BY THE CALIBRATION FACTOR (UWBC =N X103 CELLS/¿L). RAW DATA FILES WERE REQUESTED FROM THE CUSTOMER, AND HAVE NOT YET BEEN RECEIVED. BECKMAN COULTER SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE FAILURE MODE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE NUCLEATED RED BLOOD CELL (NRBC) RESULTS OBTAINED FROM THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM ON THREE DIFFERENT PATIENT SAMPLES AND RUN ON THREE DIFFERENT DAYS, WAS AFFECTING THE UWBC (UNCORRECTED WBC COUNT) AND NOT ACCURATELY CORRECTING THE WHITE BLOOD COUNT (WBC) RESULTS OBTAINED FROM THE INSTRUMENT. ALTHOUGH THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE WBC CORRECTION PERFORMED BY THE CUSTOMER WAS A MANUAL CALCULATION BASED ON THE AUTOMATED NRBC RESULTS RECOVERED BY THE INSTRUMENT. PATIENT RESULTS ARE PROVIDED IN FILE ATTACHMENT. THIS MDR IS TO REPORT RESULTS FOR PATIENT TWO (2) TESTED ON (B)(6) 2013. THREE (3) MDRS ARE BEING SUBMITTED FROM THIS ACCOUNT: 1061932-2013-01044, 1061932-2013-01045, 1061932-2013-01046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245158 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA