BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1880161 · Received October 22, 2010

    Report

    Report Number
    2050012-2010-01021
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFORMATION, THE TUBING AT NO FOAM BOTTLE WAS DISCONNECTED. CUSTOMER FITTED TUBE BACK ON TO THE BOTTLE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THEY NOTICED A LEAK ON THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1