BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3183329 · Received June 21, 2013

    Report

    Report Number
    2050012-2013-00425
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS DIRECTED TO CHECK THE SAMPLE PROBE AND FITTINGS. THE CUSTOMER CONFIRMED THAT NO ISSUES WERE OBSERVED. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 TO EVALUATE THE INSTRUMENT. THE FSE CONFIRMED THAT FLUID DRIPPED FROM THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE AFTER PERFORMING A PRIME CYCLE AND ALSO WHEN THE SYSTEM WAS IN STANDBY MODE. THE FSE REPLACED THE 2-WAY VALVE IN THE FLUID DISTRIBUTION MANIFOLD AT THE BACK OF THE INSTRUMENT WHICH RESOLVED THE LEAK. THE FAILURE MODE IS THE 2-WAY VALVE WHICH WAS REPLACED BY BEC SERVICE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE SAMPLE PROBE WAS LEAKING IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF OCCURRENCE 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 PATIENT RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283028 UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1