BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2832674 · Received November 14, 2012

    Report

    Report Number
    2050012-2012-01851
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH TROUBLESHOOTING WITH BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS). THE CUSTOMER INDICATED CONTROLS WERE WITHIN RANGE PRIOR TO AND AFTER THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY LOW SODIUM (NA) RESULT, FOR ONE PATIENT, INVOLVING THE UNICEL DXC 600 SYNCHRON SYSTEM. FIVE PATIENT SAMPLES WERE REANALYZED AND ONLY ONE HAD AN ERRONEOUS RESULT. THE ERRONEOUS RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED QUALITY CONTROL (QC) FOR SODIUM, CHLORIDE, AND CALCIUM WAS ERRATIC. THE CUSTOMER STATED FLOWCELL MAINTENANCE WAS CURRENT AND ALL ION SELECTIVE ELECTRODE (ISE) REAGENTS WERE REPLACED. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO USE PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) AND REPLACE THE SODIUM AND CHLORIDE ELECTRODES. REPLACEMENT OF THE NA AND CL ELECTRODES RESOLVED THE ISSUE. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1