BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2912550 · Received January 13, 2013

    Report

    Report Number
    2050012-2013-00018
    Event Type
    Malfunction
    Date Received
    January 13, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM (DXC 880I) WAS LEAKING BLADE WASHER FLUID. CUSTOMER REPORTED THEY NOTICED THE LEAK WHEN THEY OBSERVED CLEAR LIQUID ON THE TOPS OF THE SAMPLE TUBE CAPS. CUSTOMER REPORTED THE LEAK WAS CONFINED TO THE INTERIOR OF THE INSTRUMENT. CUSTOMER INDICATED THE VOLUME OF THE LEAK WAS APPROXIMATELY 5 - 10 MILLILITERS. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO EVALUATE THE INSTRUMENT. THE FSE DETERMINED LINE #118 WAS OBSTRUCTED. THE FSE FLUSHED THE LINE WITH BLEACH. THE FSE DID NOT OBSERVE ANY FURTHER LEAKS AFTER FLUSHING THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19479 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