BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1937281 · Received December 23, 2010

    Report

    Report Number
    2050012-2010-01670
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS UNSURE OF WHAT FLUID IS LEAKING. A BCI FIELD SERVICE ENGINEER (FSE) FOUND THAT THE WASH BUFFER WAS GETTING INTO AUTOGLOSS WELL. FSE PERFORMED THE FOLLOWINGS: REPLACED THE PERIPUMP TUBES CLEANED AUTOGLOSS WELL. RE-TAPED WASH BUFFER CONNECTOR ON RESERVOIR WHICH WAS LEAKING. PRIMED THE SYSTEM THE ISSUE HAS BEEN FIXED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO CLOSE TUBE ACCESSION (CTA) LEAK. NO INJURY AND/OR PERSONNEL EXPOSURE TO CHEMICAL OR BIO-HAZARDOUS MATERIAL WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1