BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2060434 · Received April 16, 2011

    Report

    Report Number
    2050012-2011-01138
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS NOT PROVIDED, BUT THE CUSTOMER STATED THAT QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. PER THE CUSTOMER, QC WAS NOT RE-RUN AFTER THE EVENT. BCI FIELD SERVICE ENGINEER (FSE) REMOVED AND REBUILT FLOW CELL. UPON REMOVING CO2 MEASURE ELECTRODE, THE FSE NOTICED THAT MEMBRANE WAS NOT CENTERED. ALSO, THE MEMBRANE RETAINING RING WAS CRACKED. THE FSE REPLACED RETAINER, RING, AND MEMBRANE, AND VERIFIED INSTRUMENT PERFORMANCE. HARDWARE ISSUE MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND STATED THAT UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS GENERATED FALSE LOW SODIUM (NA) RESULTS FOR MULTIPLE PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LAB. WHEN THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RECOVERY WAS A LITTLE HIGHER AND RESULTS WERE AMENDED. THE CUSTOMER PROVIDED PRINTOUTS FROM TWELVE PATIENTS. HOWEVER, OF THE TWELVE, ONE PATIENT REPEATED EXACTLY THE SAME UPON RERUN, AND THE DIFFERENCE IN RESULTS FOR FIVE PATIENTS WAS WITHIN THE PRECISION OF THE ASSAY. THE LAB HAS NOT RECEIVED ANY REPORTS THAT ANY PATIENT TREATMENTS WERE IMPACTED BASED UPON THE FALSE RESULTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1