BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3559749 · Received January 7, 2014

    Report

    Report Number
    2050012-2014-00010
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    December 20, 2013
    Report Date
    December 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED. THE FSE REPLACED THE MC SAMPLE SYRINGE TO RESOLVE THE ISSUE. THE FAILURE MODE APPEARED TO BE THE MC SAMPLE SYRINGE (PN 255579). (B)(4).

    Description of Event or Problem · 1

    THE DXC 600 GENERATED SEVERAL FALSE LOW NA (SODIUM) RESULTS. NONE WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER PROVIDED AS AN EXAMPLE A RESULT OF 132 /133 MMOL/L. THE SAMPLE WAS REPEATED ON THE SAME DXC AFTER RECALIBRATION WITH A RESULT OF 137 MMOL/L, WHICH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9799 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1