BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2251208 · Received September 9, 2011

    Report

    Report Number
    1061932-2011-01383
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    September 15, 2009
    Report Date
    September 15, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THE ROOT CAUSE WAS AN ANOMALY IN THE SOFTWARE ALGORITHM THAT WAS SUBSEQUENTLY CORRECTED IN THE NEXT SOFTWARE RELEASE (1.1.2.0).

    Description of Event or Problem · 1

    AN IN-HOUSE SOFTWARE ENGINEER NOTED THAT THE DHX 800 INSTRUMENT ALWAYS REPORTS ZERO FOR THE NRBC (NUCLEATED RED BLOOD CELL) REGION IN DAILY CHECKS. DAILY CHECKS ARE PART OF THE DXH 800 SYSTEM QUALITY ASSURANCE AND THEY REPORT BACKGROUND COUNTS. IF THE NRBC REGION BACKGROUND FAILS BUT IS NOT DETECTED, SOME SUBSEQUENT SAMPLES MAY BE REPORTED WITH FALSELY INCREASED NRBC%. AS THE PROBLEM WAS DISCOVERED IN-HOUSE, NO ACTUAL PATIENT RESULTS WERE GENERATED AND THERE WERE NO REPORTED CHANGES TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK