BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2080863 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01427
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    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
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, QC AND PATIENT RESULTS ARE NORMAL.CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO CHECK FITTING ON THE CC SAMPLE PROBE AND SYRINGES. THE CUSTOMER CONFIRMED BOTH FITTINGS WERE TIGHT. CUSTOMER PERFORMED A PRIME AND OBSERVED THE PROBE FOR LEAKS. NO LEAKS WERE OBSERVED AT THIS TIME.ON (B)(6) 2011, A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE WASH COLLAR.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE LEAK. THE CUSTOMER NOTICED FLUID ON THE SAMPLE CAROUSEL COVER. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1