BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3251119 · Received July 29, 2013

    Report

    Report Number
    2050012-2013-00520
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND THAT THE COLLAR WASH VALVE WAS NOT OPENING. THE VALVE WAS REPLACED WHICH RESOLVED THE ISSUE. THE FSE VERIFIED SYSTEM PERFORMANCE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER WAS LEAKING FROM A CARTRIDGE CHEMISTRY (CC) PROBE. THE VOLUME OF LEAKED FLUID WAS DESCRIBED AS LESS THAN 5 ML AND CONTAINED ON THE REACTION WHEEL COVER INSIDE THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND PROTECTIVE EYEWEAR 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 PATIENT RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351665 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