BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2565204 · Received May 8, 2012

    Report

    Report Number
    2050012-2012-01088
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    April 13, 2012
    Report Date
    April 13, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM GAVE A BACK TO BACK ERROR WHEN HE TRIED TO CALIBRATE THE ELECTROLYTES. CUSTOMER REPORTED THAT THE MODULAR CHEMISTRY (MC) SAMPLE PROBE WAS SPLASHING LIQUID. CUSTOMER REPORTED THAT A VERY SMALL AMOUNT OF FLUID LEAKED. CUSTOMER REPORTED THAT QUALITY CONTROL RAN BEFORE THE INCIDENT WAS PERFECT. BEC CUSTOMER TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO PERFORM ALIGNMENT ON THE (MC) SAMPLE PROBE TO CONFIRM THAT THE PROBE WAS SITTING PROPERLY IN THE WASH COLLAR. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM AND DETERMINED THAT THE TUBING FITTINGS TO THE T-VALVE FOR BOTH THE MODULAR CHEMISTRY AND CARTRIDGE CHEMISTRY SYRINGES WERE LOOSE. THE FSE SECURED ALL FITTINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1