BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2110745 · Received June 2, 2011

    Report

    Report Number
    2050012-2011-02089
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2001 A BCI FIELD SERVICE ENGINEER (FSE) NOTED THE WASTE VALVE WAS NOT OPENING AND PROCEEDED TO REPLACE THE WASTE VALVE ON REAGENT PROBE B.AS OF (B)(6), 2011, NO FURTHER ISSUES BEEN REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO CARTRIDGE CHEMISTRY REAGENT CAROUSEL LEAK. THE CUSTOMER DOES NOT KNOW WHAT THE LIQUID IS. NO INJURY WAS REPORTED AND NO PATIENT RESULTS WERE RELEASED OR AFFECTED.

    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. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1