BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2880682 · Received December 20, 2012

    Report

    Report Number
    2050012-2012-01912
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EXAMINED THE SYSTEM. THE FSE IDENTIFIED AND CLEANED A DIRTY FLOWCELL AND DRAIN. THE FSE ALSO REPLACED THE CARBON BRIDGE. THE REPAIR WAS VERIFIED BY ESTABLISHED PROCEDURES AND MEETS PUBLISHED PERFORMANCE SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER INC THAT THE UNICEL DXC 600 SYNCHRON SYSTEM GENERATED FALSE LOW SODIUM (NA) RESULTS. THE RESULTS WERE REPORTED OUT OF THE LAB. THE SYSTEM WAS RECALIBRATED AND SAMPLES REPEATED WITH RESULTS OF APPROXIMATELY 5-6 MMOL/L HIGHER WHEN THE PHYSICIANS QUESTIONED THE INITIAL RESULTS. ALTHOUGH THE CUSTOMER STATED THAT QUALITY CONTROL (QC) ON THE DAY OF THE EVENT WAS WITHIN RANGE, THE CUSTOMER'S RANGE IS WIDE, AND QC DATA PROVIDED SHOWED THAT BOTH LEVELS WERE APPROXIMATELY 4 MMOL/L LOW ON THE DAY OF THE EVENT. THE CUSTOMER STATED THAT APPROXIMATELY 46 PATIENTS WERE AFFECTED, BUT PROVIDED ONLY INCORRECT VS. CORRECT DATA FOR 11 PATIENTS DOCUMENTED AS BEING ERRONEOUSLY LOW. THERE WAS NO CHANGE TO THE PATIENTS CARE OR TREATMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE TO EVALUATE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1