BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2379780 · Received December 16, 2011

    Report

    Report Number
    2050012-2011-08441
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Date of Event
    November 19, 2011
    Report Date
    November 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 800 SYNCHRON SYSTEM TOTAL PROTEIN MODULE TPM DISABLED ITSELF. CUSTOMER REPORTED THAT THERE WAS A LOT OF DRIED BLUE REAGENT AROUND THE MODULE AND THAT IT WAS WET. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) CHANGED A LEAKING SYRINGE FOR THE REAGENT PUMP AND THE STIRRER BAR. THE FSE PERFORMED CALIBRATION AND MULTIPLE QUALITY CONTROL PRECISION RUNS. THE FSE VERIFIED THE REPAIR WAS PERFORMED PER ESTABLISHED PROCEDURES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1