BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2151780 · Received July 6, 2011

    Report

    Report Number
    1061932-2011-00843
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 18, 2011
    Report Date
    June 8, 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

    ERRONEOUS DIFFERENTIAL RESULTS OCCURRED ON A SPECIFIC PATIENT SAMPLE. THE SPECIMEN WAS DRAWN INTO 3ML K3 EDTA GREINER TUBE. THE SAMPLE WAS ANALYZED >2 HOUR AFTER DRAWN. QC WAS RUN BEFORE THE EVENT. THE INSTRUMENT IS PERFORMING WITH QC SPECIFICATIONS. RAW DATA WAS NOT PROVIDED SINCE IT IS NO LONGER AVAILABLE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GAVE ERRONEOUS DIFFERENTIAL RESULTS WITHOUT INSTRUMENT GENERATED MESSAGES FOR THE SAME SPECIMEN AS COMPARED TO MANUAL SMEAR REVIEW. PATIENT RESULTS ARE PROVIDED. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO CHANGE TO PATIENT TREATMENT AS A RESULT OF 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1