BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2221889 · Received August 24, 2011

    Report

    Report Number
    2050012-2011-04744
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) ADVISED THE CUSTOMER TO POWER THE INSTRUMENT DOWN AND OFFLOAD REAGENT PACKS FROM THE UPPER AND LOWER REAGENT CAROUSELS. THE CUSTOMER WAS ALSO ASKED TO REMOVE THE REACTION CAROUSEL TO CHECK THE TROUGH BELOW THE WHEEL FOR FLOODING. A FIELD SERVICE ENGINEER WAS ON-SITE (B)(6) 2011 AND FOUND THE VACUUM TUBING GETTING KINKED POSSIBLY REDUCING VACUUM FOR REAGENT PROBE WASH COLLAR. FSE REMOVED EXCESS TUBING AND STRAIGHTENED TUBING AND TIGHTENED ALL FLUID CONNECTIONS FOR REAGENT PROBES, BUBBLE GENERATOR AND T-VALVE. THE REPAIRS PERFORMED BY THE FSE RESOLVED THE ISSUE. THE BEC INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING AN ISSUE ON THE CARTRIDGE CHEMISTRY (CC) SIDE OF THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. A REAGENT PROBE WAS LEAKING ON THE REACTION WHEEL AND COVER. THE CUSTOMER WAS GETTING BLANK ERRORS ON TRANSFERRIN AND NO RESULTS ON IRON. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1