BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM

    MDR report key: 2981789 · Received February 27, 2013

    Report

    Report Number
    2050012-2013-00123
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256 RR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MODULAR CHEMISTRY (MC) PROBE OF A UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER INDICATED THAT AN ERROR MESSAGE WAS GENERATED WHEN THE LEAK OCCURRED. THE LEAK WAS CONTAINED TO THE INSTRUMENT BUT FLUID WAS OBSERVED ON THE TOP OF ONE SAMPLE TUBE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AND THERE WAS NO INJURY OR EXPOSURE. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DETERMINED THAT THE LEAK FROM THE PROBE WAS A DILUTED WASH SOLUTION. THE FSE REPLACED A FAULTY VACUUM WASH COLLAR VALVE AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84500 UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1