BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2042736 · Received April 6, 2011

    Report

    Report Number
    1061932-2011-00231
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 20, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIMENS WERE COLLECTED IN 12 X 75 MM EDTA TUBES AND WERE SAMPLED WITHIN 17 MINUTES OF COLLECTION. SPECIMENS WERE STORED AT ROOM TEMPERATURE. THE INSTRUMENTS ARE PERFORMING WITHIN QC SPECIFICATIONS. CONTROLS WERE RUN BEFORE THE INCIDENT AND RECOVERED WITHIN ASSAY LIMITS. BCI FIELD SERVICE ENGINEER (FSE) PERFORMED START UP, RAN LATRON AND CONTROLS. THE SYSTEM WORKS WITHIN SPECIFICATIONS. RAW DATA WAS REQUESTED BUT NOT AVAILABLE. AT THIS TIME, ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE UNICEL DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS DIFFERENTIAL RESULTS (HIGH MO% AND LOW NE%) ON 1 PATIENT. THESE RESULTS, PROVIDED TO BCI, WERE BASED ON LIS REPORTS AND IT IS UNKNOWN IF THE INSTRUMENT FLAGGED THESE RESULTS. A MANUAL DIFFERENTIAL PERFORMED ON THE SAME SAMPLE GENERATED LOWER MO% AND HIGHER NE% RESULTS. RESULTS WERE NOT REPORTED OUTSIDE OF THE LAB. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH 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. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1