BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2110818 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01948
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC HAS BEEN WITHIN ESTABLISHED RANGES BEFORE AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND INSPECTED THE ENTIRE GLUCOSE (GLU) MODULE HARDWARE AND ASSOCIATED INSTRUMENT SAMPLE HANDLING HARDWARE BUT COULD NOT FIND A ROOT CAUSE. PER CUSTOMER, IT COULD HAVE BEEN A SAMPLE HANDLING ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ONE ERRONEOUSLY HIGH GLUCOSE (GLU) RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WHEN RUNNING IN CRITICAL RERUN MODE. INITIAL RESULT WAS 116MG/DL AND RERUN WAS 130MG/DL. RERUN ON ALTERNATE ANALYZER WAS 120/120MG/DL AND WAS REPORTED. THERE WAS NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THE CUSTOMER RUNS GLU IN CRITICAL RERUN MODE AND VERIFIES THE RESULTS ON THEIR ANALYZER PRIOR TO REPORTING THE RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR