BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2155729 · Received July 11, 2011

    Report

    Report Number
    2050012-2011-02797
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. PER THE CUSTOMER, QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) REPLACED THE NA MEASURING ELECTRODE, CLEANED AND ALIGNED THE MODULAR CHEMISTRIES (MC) SAMPLE PROBE. THE FSE VERIFIED THE INSTRUMENT PERFORMANCE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM INTERMITTENTLY GENERATED FALSE HIGH SODIUM (NA) RESULTS. THESE RESULTS WERE NOT REPORTED OUT OF THE LAB. WHEN LOW ANION GAPS ALERTED THE LAB, THE SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT IN THE LAB, AND THOSE RESULTS WERE REPORTED. THE CUSTOMER PROVIDED 3 PATIENT REPORTS. ONE REPORT THAT SHOWED THE ISSUE, AND 2 REPORTS THAT AGREED BETWEEN INSTRUMENTS. THERE WAS NO EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1