BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2880641 · Received December 19, 2012

    Report

    Report Number
    2050012-2012-01954
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH TROUBLESHOOTING. THE INSTRUMENT WAS IN NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ION SELECTIVE ELECTRODE (ISE) REFERENCE NOISE ERRORS FOR SODIUM (NA) AND CALCIUM (CA) DURING CALIBRATION AND FLUID LEAKED AT THE BASE OF THE ISE MODULE, THE DRIP TRAY, AND A SMALL AMOUNT ON THE FLOOR, INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER HAD ON PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND FACE SHIELD AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT SAMPLES WERE NOT ANALYZED AND RESULTS WERE NOT GENERATED. THE CUSTOMER PERFORMED TROUBLESHOOTING AND REFITTED TUBING #15 AND RESOLVED THE ISSUE. THE CUSTOMER CLEANED AND RINSED THE FLUID SPILL AND VERIFIED REPAIRS BY PRIMING ALL ISES FIFTEEN TIMES TO VERIFY SYSTEM OPERATION. THE INSTRUMENT PERFORMED WITHIN SPECIFICATIONS.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1