BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2250934 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05435
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER WITH REPLACING THE THREE-WAY VALVE OVER THE PHONE. THE LEAK STOPPED AFTER REPLACEMENT OF THE VALVE. CUSTOMER REPORTED THAT THEY REPLACED THE SYRINGE BARREL AND PLUNGER ON TWO OCCASIONS. THIS IS ONE OF TWO REPORTS RELATED TO THE EVENTS THAT OCCURRED ON TWO DIFFERENT DAYS. THIS MDR IS RELATED TO MDR# 2050012-2011-05562. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) ON (B)(6) 2011 THAT THEY OBSERVED A LEAK INTERMITTENTLY COMING FROM THE MODULAR CHEMISTRY SAMPLE SYRINGE AREA OF THE UNICEL DXC 800 SYNCHRON SYSTEM. CUSTOMER REPORTED THAT THEY REPLACED THE SYRINGE BARREL AND PLUNGER ON (B)(6) 2011. CUSTOMER REPORTED THAT FLUID IS STILL PRESENT ON THE BACK SIDE OF COVER BEHIND THE SYRINGE AFTER REPLACEMENT OF THE SYRINGE BARREL AND PLUNGER. CUSTOMER REPORTED THAT THERE WERE NO ERRONEOUS RESULTS. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1