BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1905073 · Received November 22, 2010

    Report

    Report Number
    2050012-2010-01336
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 22, 2010
    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 AND FOUND A LEAKING SYRINGE PUMP ON THE TOTAL PROTEIN MODULE, REPLACED IT AND PERFORMED THE CUP MONTHLY MAINTENANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING TOTAL PROTEIN (TP) RESULTS WERE SUPPRESSED AND FLAGGED WITH IL (INITIAL RATE LOW) ON THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1