BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3791584 · Received May 6, 2014

    Report

    Report Number
    2050012-2014-00229
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE FOUND THAT THE WASTE VACUUM THREE-WAY SOLENOID VALVE WAS NON-FUNCTIONING AND REPLACED THE PART. THE FSE PERFORMED ALIGNMENTS AND OBSERVED NO FURTHER LEAKS. THERE WERE NO FURTHER REPORTS OF LEAKS OR PROBE OBSTRUCTIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CAP PIERCER OF A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WAS GENERATING MODULAR CHEMISTRY (MC) AND CARTRIDGE CHEMISTRY (CC) PROBE OBSTRUCTION ERRORS; THE CUSTOMER STATED THESE ERRORS OCCURRED AFTER REPLACING THE WICK. THE CUSTOMER ALSO REPORTED LIQUID LEAKING FROM THE CAP PIERCER ONTO SAMPLE TUBE CAPS. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT WHEN THE LEAK OCCURRED. THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK OR OF INJURY DUE TO THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED AS A RESULT OF THIS LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270387 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