BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2626706 · Received June 22, 2012

    Report

    Report Number
    2050012-2012-01327
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 28, 2012
    Report Date
    May 28, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 ENZYME QUALITY CONTROL (QC) RAN ON THE UNICEL DXC 800 SYNCHRON SYSTEM WAS OUT 3 STANDARD DEVIATIONS. CUSTOMER REPORTED THAT WHEN THEY INSPECTED THE INSTRUMENT, THEY FOUND THE CARTRIDGE CHEMISTRY (CC) REAGENT PROBE B WAS LEAKING. CUSTOMER REPORTED THAT A MINIMUM OF 5 ML OF LIQUID WAS ON THE INSTRUMENT. CUSTOMER REPORTED THAT THE LEAK WAS CONTAINED IN THE INSTRUMENT. CUSTOMER INDICATED THAT THE LEAK WAS MOSTLY CONTAINED ON THE CC REAGENT DRIP TRAY AND SOME ON THE CC REACTION WHEEL COVER. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND A LOOSE REAGENT SYRINGE. THE FSE SECURED THE REAGENT SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1