BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2995804 · Received March 8, 2013

    Report

    Report Number
    2050012-2013-00161
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE CONFIRMED AN OVERFLOWING EIC AND DETERMINED THE CAUSE WAS AN OBSTRUCTION IN THE EIC WASTE PORT. THE OBSTRUCTION WAS CLEARED AND THE INSTRUMENT RESTORED TO SPECIFICATIONS. THE FAILURE MODE IS AN OBSTRUCTED EIC PORT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER'S ELECTROLYTE INJECTION CUP (EIC) WAS OVERFLOWING AND NOT DRAINING. THE CUSTOMER STATED THAT FLUID LEAKED FROM THE EIC CUP AND DOWN ONTO THE LABORATORY FLOOR. THE CUSTOMER WAS WEARING PROPER PROTECTIVE EQUIPMENT (PPE), INCLUDING GLOVES, PROTECTED EYEWEAR, AND A LABORATORY COAT DURING THIS EVENT. THERE WERE NO INJURIES AND NO ONE HAD TO SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100032 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1