BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1943252 · Received December 31, 2010

    Report

    Report Number
    2050012-2010-01765
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE PERI PUMP TUBING AND THE SYSTEM WAS RESUMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A SHORT SAMPLE ERROR ON UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER FOUND AUTOGLOSS WAS LEAKING AROUND THE WASH CUP DUE TO BUILDUP. ALTHOUGH THE AUTOGLOSS IS NOT A HAZARDOUS REAGENT, THE LEAK AROUND THE WASH CUP MAY CONTAIN BIOHAZARDOUS MATERIAL. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1