BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2697492 · Received August 14, 2012

    Report

    Report Number
    2050012-2012-01419
    Event Type
    Malfunction
    Date Received
    August 14, 2012
    Date of Event
    July 20, 2012
    Report Date
    July 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY NOTICED TWO RACKS WITH PATIENT SAMPLES ON THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM HAD WATER ON TOP OF THE TUBE CAPS. CUSTOMER REPORTED THAT THERE WAS LIQUID DRIPPING FROM THE MODULAR CHEMISTRIES (MC) SAMPLE PROBE. CUSTOMER REPORTED THAT THE VOLUME OF THE LEAK FROM THE MC SAMPLE PROBE WAS APPROXIMATELY 5 ML. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) IDENTIFIED A FAULTY MODULAR CHEMISTRIES SAMPLE PROBE VACUUM VALVE. THE FSE REPLACED THE VALVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1