BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1971329 · Received January 27, 2011

    Report

    Report Number
    2050012-2011-00251
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED ALL QC RESULTS WERE WITHIN SPECIFICATIONS AND NO SYSTEM ERROR MESSAGE WAS RECEIVED. A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND FOUND WHAT APPEARED TO BE GEL FROM SAMPLE TUBES CLOGGED INTO THE SAMPLE PROBE WASH COLLAR VACUUM/WASTE VALVE. THE FSE REMOVED THE GEL CLOT, CLEANED THE VALVE AND RE-INSTALLED. THE FSE RAN ALL QC TO VERIFY THE INSTRUMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAKING ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. INCORRECT RESULTS WERE GENERATED AND REPORTED OUT OF THE LABORATORY. PER CUSTOMER, NO PATIENT TREATMENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1