BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 3110255 · Received May 13, 2013

    Report

    Report Number
    2050012-2013-00342
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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

    UPON TROUBLESHOOTING, THE CUSTOMER FOUND THAT THE REAGENT SYRINGE ASSEMBLY WAS NOT FULLY ENGAGED TO THE SYRINGE 3-WAY SHEAR VALVE. THE CUSTOMER TIGHTENED AND SECURED THE REAGENT SYRINGE AND CHECKED ALL FITTINGS. REAGENT DELIVERY SUBSYSTEM WAS PRIMED AND NO FURTHER LEAKS WERE OBSERVED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER CORRECTED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A CARTRIDGE CHEMISTRY (CC) REAGENT SYRINGE LEAK IN THE UNICEL DXC 600 SYNCHRON CHEMISTRY ANALYZER. THE INSTRUMENT ALSO GENERATED A "CC SAMPLE CUVETTE NO FLUID DETECTED" ERROR, WHICH ALERTED THE OPERATOR OF AN ISSUE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, EYE PROTECTION, AND A LABORATORY COAT WHEN THE LEAK WAS DISCOVERED AND DURING TROUBLESHOOTING. 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. 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
    210854 UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1