BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2210839 · Received August 12, 2011

    Report

    Report Number
    2050012-2011-04446
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO USE PPE BEFORE TROUBLESHOOTING THE INSTRUMENT. THE CUSTOMER FOUND THE REAGENT SYRINGE LOOSE, AND TIGHTENED THE REAGENT SYRINGE. NO SERVICE REQUEST WAS GENERATED AS THE ISSUE WAS RESOLVED BY TROUBLESHOOTING WITH CTS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ERROR MESSAGES OF "CUVETTE NOT DRY BEFORE REAGENT DISPENSE" WERE RECEIVED ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER ALSO REPORTED THAT A SLIGHT SEEPAGE OCCURRED AT THE REAGENT PROBES. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1