BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2042784 · Received April 7, 2011

    Report

    Report Number
    2050012-2011-00982
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND REPORTED THAT REAGENT CAROUSEL SHOWED SIGNS OF LEAKAGE. THERE WERE NO MECHANICAL ISSUES OR RESULT ERRORS. FSE REMOVED FRONT OF REAGENT CAROUSEL AND INSPECTED AND FOUND EVIDENCE OF LEAKING BUT NO SIGNS OF CURRENT PROBLEMS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THERE WAS BUILD UP ON REAGENT CAROUSEL WHICH WAS MAKING REAGENT LOADING DIFFICULT. NO INJURY WAS REPORTED.

    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