BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2379796 · Received December 16, 2011

    Report

    Report Number
    2050012-2011-08442
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Date of Event
    November 19, 2011
    Report Date
    November 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: COLLAR WASH. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT CALIBRATION ON THE DRUG SCREEN WAS FAILING BACK TO BACK ON THE UNICEL DXC 800 SYNCHRON SYSTEM. CUSTOMER REPORTED THAT THERE WERE DISCOLORED FLUID DRIPS ON THE REAGENT CAROUSEL DRIP TRAY. 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 THE ROOT CAUSE WAS THE COLLAR WASH. THE FSE FOUND THE 100 UL CARTRIDGE CHEMISTRY (CC) SAMPLE SYRINGE WAS DISCOLORED AND CARRYOVER WAS SEEN FROM THE PROBE B COLLAR WASH. THE FSE FOUND A "BAD SPRAY PATTERN" IN THE SAMPLE MIXER WASH STATION. THE FSE REPLACED THE 100 UL SYRINGE, THE MIXER WASH INSERT ASSEMBLY, AND THE COLLAR WASH VERTICAL MOUNTING. THE FSE PERFORMED PRECISION VERIFICATION TEST AND CHECKED QUALITY CONTROL AND DID NOT NOTICE ANY PROBLEMS. THE FSE VERIFIED THE REPAIR WAS PERFORMED PER ESTABLISHED PROCEDURES.

    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