BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2072844 · Received April 29, 2011

    Report

    Report Number
    1061932-2011-00328
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 31, 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

    SPECIMEN WAS COLLECTED IN A 5ML EDTA VACUTAINER TUBE AND SAMPLED WITHIN 20 MINUTES OF COLLECTION. SPECIMEN WAS STORED AT ROOM TEMPERATURE. THE INSTRUMENT IS PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPEATABILITY (PRECISION). CONTROLS WERE RUN BEFORE AND AFTER THE EVENT AND ALL RECOVERED WITHIN ASSAY LIMITS. RAW DATA COULD NOT BE OBTAINED AS THE CUSTOMER HAD DELETED THE FILES. 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 RESULT OF 0.0059 FOR NRBC% ON 1 PATIENT. REPEAT ANALYSIS OF THE SAMPLE GENERATED A ::::: (FLOW CELL CLOG DETECTED) RESULT INSTEAD OF NRBC RESULTS. A MANUAL COUNT WAS PERFORMED AND FOUND 80% NRBC. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. RESULT OF THE MANUAL COUNT WAS ACCEPTED AS THE CORRECT RESULT AND WAS REPORTED OUT. 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