BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3607147 · Received February 4, 2014

    Report

    Report Number
    2050012-2014-00068
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE OBSERVED LEAKING FROM THE LEFT SOLENOID VALVE ON THE EIC. THE FSE REPLACED THE SOLENOID VALVE, HOWEVER, LEAKING FROM THE EIC PERSISTED. THE FSE THEN REPLACED THE EIC ASSEMBLY WHICH RESOLVED THE ISSUE. THIS FAILURE MODE CAN IMPACT ANY OR ALL CHEMISTRIES, INCLUDING CRITICAL CHEMISTRIES. THE MANUFACTURER REFERENCE NUMBER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A CONTAINED LEAK FROM THE ELECTROLYTE INJECTION CUP (EIC) ON THEIR UNICEL DXC 600I INSTRUMENT. THE LEAK CONSISTED OF LESS THAN 1 CC OF FLUID CONTAINED WITHIN THE ISE MODULE INSTRUMENT. NO EXPOSURE TO THE FLUID OR INJURIES WERE REPORTED. NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72317 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1