BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2155735 · Received July 11, 2011

    Report

    Report Number
    2050012-2011-02798
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM PER THE CUSTOMER, QC HAS BEEN WITHIN LAB-ESTABLISHED RANGES. QC DATA WAS REQUESTED, BUT NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) REPLACED THE CARBON BRIDGE AND VERIFIED PERFORMANCE. 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 FALSE LOW SODIUM (NA) AND FALSE HIGH CHLORIDE (CL) RESULTS GENERATED BY THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM FOR TWO PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. WHEN ANION GAPS ON THE SAMPLES ALERTED THE LAB, THE SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT IN THE LAB, AND THOSE RESULTS WERE REPORTED. 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