BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO® SYNCHRON CLINICAL SYSTEM

    MDR report key: 2111202 · Received June 2, 2011

    Report

    Report Number
    2050012-2011-02071
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT PROVIDED. CONTROLS RUN BEFORE AND AFTER INCIDENT WERE WITHIN ESTABLISHED RANGES. ON (B)(4) 2011, BCI CUSTOMER TECHNICAL SUPPORT (CTS) DISCUSSED PROPER SAMPLE HANDLING WITH CUSTOMER. CTS ADVISED CUSTOMER TO PERFORM CUVETTE WASH PROCEDURE, HAD CUSTOMER PERFORMED QC AND RAN PRECISION TEST. ON (B)(4) 2011, CUSTOMER REPORTED THAT INSTRUMENT WAS GENERATING MULTIPLE REAGENT SYRINGE MOTION ERROR. ON (B)(4) 2011, FIELD SERVICE ENGINEER (FSE) EVALUATED INSTRUMENT AND FOUND LEAK FROM REAGENT PROBE A, AND PUDDLE OF WATER ON THE COVER BENEATH THE PROBE. FSE REPLACED COMPONENTS TO ADDRESS THIS ISSUE, PERFORMED TOP END ALIGNMENT, AND VERIFIED WASH STATION PERFORMANCE, RAN CARRYOVER PROCEDURE TEST AND RESULTS MET SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE UNICEL DXC 600 PRO INSTRUMENT GENERATED TWO (2) FALSE HIGH % HEMOGLOBIN ((B)(6)). RESULTS WERE REPORTED OUT OF THE LAB. REPEAT TESTING GENERATED LOWER RESULTS AND PATIENT REPORTS WERE AMENDED. THE CUSTOMER NOTIFIED THE PHYSICIANS OF THE FALSE RESULTS AND CONFIRMED THAT NO PATIENT TREATMENT WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO® SYNCHRON CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1