BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2342594 · Received November 18, 2011

    Report

    Report Number
    2050012-2011-07561
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 25, 2011
    Report Date
    October 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A LEAK FROM THE BACK ON THE 10 PSI REGULATOR OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. CUSTOMER ALSO REPORTED HEARING A HISSING SOUND FROM THE BACK OF THE REGULATOR. THE CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED CUSTOMER WITH TROUBLESHOOTING THE INSTRUMENT BY ADVISING CUSTOMER TO PRESS THE STOP KEY, THEN HOME THE UNIT. AFTER FURTHER TROUBLESHOOTING, THE LEAK ISSUE WAS RESOLVED AND THE CTS WAS ABLE TO VERIFY WITH CUSTOMER THAT THE TROUBLESHOOTING EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. CUSTOMER STATED THAT NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THAT NO ONE WAS AFFECTED BY THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600I

    Patients

    Seq Age Sex Outcome Treatment
    1