BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 3243759 · Received July 23, 2013

    Report

    Report Number
    2050012-2013-00512
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TIGHTENED THE FITTING BUT ISSUE WAS STILL UNRESOLVED. THE REAGENT PROBE CONTINUED TO LEAK INTERMITTENTLY. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND THE CAUSE OF THE REAGENT PROBE B LEAK TO BE DUE TO A FAULTY SOLENOID VACUUM VALVE FOR COLLAR WASH. THE FSE REPLACED THE SOLENOID VACUUM VALVE WHICH RESOLVED THE ISSUE. 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 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER ALSO REPORTED THAT ALL CARTRIDGE CHEMISTRIES WERE FAILING QUALITY CONTROL (QC) GREATER THAN A THREE (3) STANDARD DEVIATION. UPON TROUBLESHOOTING QC FAILURES WITH BEC CUSTOMER TECHNICAL SUPPORT (CTS), THE CUSTOMER OBSERVED THAT THE REAGENT PROBE B LEAK WAS CAUSED BY A LOOSE FITTING. APPROXIMATELY 5 CUBIC CENTIMETERS (CCS) OF FLUID WAS FOUND IN THE REAGENT PROBE DRIP TRAY AND WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES DURING THIS EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS DUE TO THE CONTAINED LEAK. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342713 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1