BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2140214 · Received June 25, 2011

    Report

    Report Number
    2050012-2011-02682
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 26, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES. QC RUN AFTER THE LOW RECOVERY WAS NOTICED WAS LOW. THE SYSTEM WAS RECALIBRATED AND QC WAS ACCEPTABLE. ISE (ION-SELECTIVE ELECTRODE) HEALTH CHECK TESTING PASSED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM WHICH WERE REPORTED OUTSIDE OF THE LABORATORY. WHEN THE TREND WAS NOTICED, THE SYSTEM WAS RECALIBRATED AND SAMPLES WERE RERUN. THE RESULTS WERE HIGHER AND THE REPORTS WERE AMENDED. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1