BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2003392 · Received March 1, 2011

    Report

    Report Number
    2050012-2011-00551
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    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 ANION GAP VALUES ALERTED THE LAB TO THE ISSUE. QC PRIOR TO THE EVENT WAS WITHIN THE LAB-ESTABLISHED RANGES. QC WAS NOT RUN AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE FOUND AND REMOVED A BUBBLE ON THE FACE OF THE NA REFERENCE ELECTRODE. THE ISE TUBING WAS PULLED TOO TIGHT, CREATING A "PINCH". THE FSE REPLACED THE TUBING, CO2 MEMBRANE, CARBON BRIDGE, AND VERIFIED REPAIRS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY HIGH SODIUM (NA) AND CARBON DIOXIDE (CO2) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE SAMPLES WERE REPEATED ON THE OTHER INSTRUMENT IN THE LAB AND THOSE RESULTS WERE REPORTED OUT OF THE LAB. THE FALSE HIGH 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 JGS BECKMAN COULTER INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1