BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3241822 · Received July 22, 2013

    Report

    Report Number
    2050012-2013-00508
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE REPRODUCED THE LEAK DURING A QUALITY CONTROL RUN. THE FSE NOTICED LIQUID LEAKING FROM REAGENT PROBE B THROUGH THE WASH COLLAR AT ITS HOME POSITION. THE FSE CONFIRMED THAT THE LEAK WAS DUE TO A MALFUNCTIONING SOLENOID VACUUM VALVE. THE SOLENOID VALVE HAD INSUFFICIENT VACUUM TO MOVE THE WASH SOLUTION TO WASTE. THE FSE REPLACED THE SOLENOID VACUUM VALVE WHICH RESOLVED THE ISSUE. THE FSE VERIFIED SYSTEM PERFORMANCE. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A REAGENT PROBE B LEAK IN THE UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER. AFTER THE CUSTOMER HAD PERFORMED MULTIPLE MAINTENANCE PROCEDURES ON THE SYSTEM, THE CUSTOMER OBSERVED MULTIPLE CARTRIDGE CHEMISTRIES FAILING CALIBRATION. UPON TROUBLESHOOTING THE CALIBRATION FAILURE, THE CUSTOMER DISCOVERED THE LEAK IN THE REAGENT PROBE B. APPROXIMATELY 15-20 MILLILITERS OF FLUID LEAKED AND WAS CONTAINED WITHIN THE UNIT AROUND THE REAGENT SPILL TRAY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT DURING THIS EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO ELECTRICAL OR OPTICAL COMPONENTS WERE AFFECTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340811 UNICEL® DXC 800 SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1