BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2022816 · Received March 17, 2011

    Report

    Report Number
    2050012-2011-00716
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF SYSTEM MALFUNCTION. BCI FIELD SERVICE ENGINEER (FSE) NOTED THAT THE SECOND SHIFT HAD FOUND A REAGENT CARTRIDGE THAT LEAKED IN THE PRIOR WEEK, BUT THE CUSTOMER COULD NOT REMEMBER WHICH REAGENT CARTRIDGE WAS LEAKING. THE FSE CLEANED THE REAGENT AREA AND ADVISED THE CUSTOMER TO MONITOR THE REAGENT CARTRIDGES FOR POSSIBLE LEAKAGE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A LEAK ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED AN OILY RESIDUE WAS FOUND ON THE CARTRIDGES LOADED ON THE REAGENT CAROUSEL. NO INJURY WAS REPORTED AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1