BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1917549 · Received December 8, 2010

    Report

    Report Number
    2050012-2010-01512
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND CHECKED THE INSTRUMENT. THE FSE PERFORMED (B)(4) TEST WHICH WAS ACCEPTABLE. TECHNICAL APPLICATIONS WORKED WITH THE CUSTOMER TO TROUBLESHOOT THE ISSUE. THE CUSTOMER IS USING NON-LABORATORY QUALITY FREEZERS WHICH GO THROUGH A FREEZE-THAW CYCLE TO PREVENT ICE BUILDUP. TECHNICAL APPLICATIONS PROVIDED INFORMATION TO THE CUSTOMER ABOUT THE PROBLEMS OF USING FROST-FREE FREEZERS. THE CUSTOMER ENVIRONMENTAL ISSUE MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY HIGH TOTAL BILIRUBIN (TBIL) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS FOR NINE PATIENTS. PATIENT SAMPLES WERE SENT FOR TESTING AT THE REFERENCE LAB AND LOWER RESULTS WERE OBTAINED. BCI AND THE REFERENCE LAB RESULTS ARE SHOWN. THE HIGH TBIL RESULTS WERE NOT REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1