BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2923445 · Received January 22, 2013

    Report

    Report Number
    2050012-2013-00030
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE REAGENT PROBE A OF A UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER STATED THAT ALL THE TUBING CONNECTIONS TO THE PROBE AND REAGENT SYRINGE HAD BEEN CHECKED AND VERIFIED. THE CUSTOMER WORE PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF EVENT AND THERE WAS NO REPORT OF EXPOSURE OR INJURY. THE CUSTOMER INDICATED THAT QUALITY CONTROL (QC) WAS NOT AFFECTED AND THERE WERE NO ERRONEOUS RESULTS GENERATED. THERE WAS NO CHANGE OR IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND OBSERVED MATERIAL IN THE COLLAR WASH VALVE. THE FSE PROCEEDED TO CLEAN THE VALVE AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29361 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1