BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2625325 · Received June 22, 2012

    Report

    Report Number
    2050012-2012-01290
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 27, 2012
    Report Date
    May 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 CC (CARTRIDGE CHEMISTRY) SAMPLE PROBE OF THE UNICEL DXC 600 SYNCHRON SYSTEM WAS LEAKING FLUID. CUSTOMER INDICATED THAT FLUID FROM THE CC SAMPLE PROBE LEAKED FROM THE PROBE AND DOWN ONTO THE INSTRUMENT'S DRIP TRAY. CUSTOMER REPORTED THAT THEY FOUND A LOOSE FITTING ON THE TOP OF THE CC SAMPLE PROBE. CUSTOMER REPORTED THAT THEY WERE ABLE TO TIGHTEN THE FITTING AT THE TOP OF THE CC SAMPLE PROBE. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1