BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS

    MDR report key: 2139793 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02523
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS SERUM. NA QC RUN 17 HOURS PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. THE NORMAL LEVEL NA QC RUN AFTER THE EVENT WAS ON THE LOW END OF THE LAB'S RANGE. A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND NO ISSUES. THE FSE VERIFIED THE INSTRUMENT'S PERFORMANCE. A CLEAR ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. NO FALSE RESULTS WERE REPORTED OUT OF THE LAB. WHEN THE LOW RESULTS WERE NOTICED, THE SAMPLES WERE RERUN ON A DIFFERENT INSTRUMENT IN THE LAB AND THOSE RESULTS WERE REPORTED. THE CUSTOMER PROVIDED ONLY ONE EXAMPLE WHICH IS SHOWN. PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1