BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2463126 · Received February 21, 2012

    Report

    Report Number
    2050012-2012-00496
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 A LIGHT BROWN LIQUID (ABOUT 10ML) ADHERED TO THE OUTSIDE OF THE REAGENT CARTRIDGES ON THE BOTTOM REAGENT CAROUSEL OF THE UNICEL DXC 800 SYNCHRON SYSTEM. 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) FOUND SOME EVIDENCE OF SPILLAGE IN THE REAGENT STORAGE AREA IN THE LOWER DECK. THE FSE REMOVED AND INSPECTED ALL REAGENT PACKS FOR LEAKAGE. THE FSE COULD NOT IDENTIFY ANY LEAKAGE FROM THE REAGENT PACKS. THE FSE NOTED THAT SOME OF THE REAGENT PACKS HAD BEEN THROWN OUT BY THE USER DUE TO SPILLAGE ON THEM.

    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. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1