BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1592290 · Received February 2, 2010

    Report

    Report Number
    2050012-2010-00030
    Event Type
    Malfunction
    Date Received
    February 2, 2010
    Date of Event
    January 14, 2010
    Report Date
    February 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISE SYSTEM IS ROUTINELY CALIBRATED EVERY 4 HOURS AND QC IS RUN AT THAT TIME. QC RESULTS WERE STABLE WITHIN THE LAB'S ESTABLISHED RANGES. THE CUSTOMER USES THE TWICE-WEEKLY FLOW CELL MAINTENANCE PROCEDURE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE DISASSEMBLED AND CLEANED GEL OUT OF THE FLOW CELL. THE FSE REPLACED THE ISE MODULE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS FOR MULTIPLE PATIENTS. THE ELEVATED RESULTS WERE IN THE RANGE OF 150-157 MMOL/L. THE ORIGINAL SPECIMENS WERE RE-TESTED AND LOWER RESULTS WERE GENERATED (137-140 MMOL/L). THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO AFFECT TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1