BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2141983 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02501
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS RESULTS GENERATED. A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUS GLUCOSE RESULTS FOR 14 PATIENT SAMPLES ASSAYED ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER UPON DISCOVERING UNACCEPTABLE QUALITY CONTROL RESULTS. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER CHECKED WITH THE ATTENDING NURSES AND REPORTED THAT THERE WAS NO IMPACT TO PATIENT TREATMENT. WHEN THE CUSTOMER DISCOVERED THAT THE QUALITY CONTROL RESULTS WERE UNACCEPTABLE, THE CUSTOMER RE-ASSAYED 50-60 PATIENT SAMPLES FOR GLUCOSE. OF THAT GROUP, 14 PATIENT SAMPLES REQUIRED AMENDED REPORTS FOR GLUCOSE. THE CUSTOMER REPLACED THE ANALYZER ELECTRODE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE FLUSHED OUT THE REAGENT LINES AND CHECKED MODULE OPERATION. THE CUSTOMER INCREASED THE FREQUENCY OF ANALYZING QUALITY CONTROLS TO EVERY 2 HOURS. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER CGA BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1