BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1829799 · Received September 9, 2010

    Report

    Report Number
    2050012-2010-00731
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) VISITED AND PERFORMED ROUTINE REPAIRS. A) REPLACED BOTH OF THE UCTA (LEFT AND RIGHT) WASH SYRINGES. THE REPAIRS MADE ON THE SYSTEM APPEAR TO HAVE RESOLVED THE ISSUE. UPON REOCCURRENCE, THE HARDWARE FAILURES COULD CAUSE ERRONEOUS RESULTS ON ANY CHEMISTRIES AND PATIENT TREATMENT AND/OR OPERATOR SAFETY IS LIKELY TO BE IMPACTED. THE ROOT CAUSE IS NOT KNOWN AT THIS TIME, PARTS ARE BEING SENT IN FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING EVIDENCE OF DRIED WASH BUFFER ON THE BOTTOMS OF THE RIGHT AND LEFT UCTA (UNICEL CLOSED TUBE ALIQUOTTER) WASH SYRINGES IN THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM INDICATING A LEAK IN THE SYSTEM. THE LEAKAGE FROM THE PROBE CONSISTS OF DILUTED WASH SOLUTION. THERE WAS NO IMPACT ON PATIENT TREATMENT OR USER SAFETY FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 660I NA

    Patients

    Seq Age Sex Outcome Treatment
    1