BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2880683 · Received December 20, 2012

    Report

    Report Number
    2050012-2012-01926
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGZ
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE. THE FSE DECONTAMINATED THE INSTRUMENT. THE FSE THEN REPLACED THE CARBON BRIDGE WHICH IS A REQUIRED PROCEDURE FOLLOWING SYSTEM DECONTAMINATION. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED FALSE HIGH CHLORIDE (CL) RESULTS FOR 3 PATIENT SAMPLES. AN ERRONEOUS SODIUM (NA) RESULT WAS ALSO GENERATED FOR ONE OF THE PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RETESTED AND YIELDED LOWER RESULTS IN LINE WITH CLINICAL EXPECTATION. QUALITY CONTROLS WERE WITHIN ESTABLISHED LABORATORY SPECIFICATIONS PRIOR TO THE EVENT. THERE WERE NO CHANGES TO THE PATIENTS CARE OR TREATMENT. THE CUSTOMER PROVIDED DATA FOR ONLY 2 PATIENTS OUT OF THE THREE REPORTED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CGZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1