BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1905208 · Received November 22, 2010

    Report

    Report Number
    2050012-2010-01354
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD REPLACED THE SYRINGES ABOUT 4-6 MONTHS AGO. THE CUSTOMER CONTACTED SERVICE AND THE SERVICE INSTRUCTED THE CUSTOMER TO REPLACE THE SYRINGE BARREL AND PLUNGER. THE CUSTOMER REPLACED THE PARTS AND RAN QC. NO ADDITIONAL LEAK HAS BEEN REPORTED SINCE. QA REQUESTED THE SYRINGES TO BE RETURNED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO THE UCTA SYRINGE BARREL AND PLUNGER LEAK ON THE UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. NO INJURY 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