BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2210906 · Received August 12, 2011

    Report

    Report Number
    2050012-2011-04491
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    A-2388-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED BY THE CUSTOMER. THE CUSTOMER STATED THAT QC HAD BEEN WITHIN ACCEPTABLE RANGES. ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) VERIFIED STIRRER MOTOR MAGNET HEIGHT, REPLACED MODULAR CHEMISTRY SAMPLE SYRINGE BARREL AND PLUNGER, SENSOR. THE FSE RECALIBRATED THE SYSTEM AND PERFORMED A PRECISION RUN. NO RESULT VARIED > 4 MG/DL FROM HIGHEST TO LOWEST RESULT. ON (B)(4) 2011, THE FSE RELOADED THE SOFTWARE VERSION 4.92, ADJUSTED MODULAR CHEMISTRY SAMPLE PROBE VERTICAL HEIGHT, AND REPLACED THE T-VALVE ASSEMBLY. RELATED MDRS: 2050012-2011-04494, 2050012-2011-04488, 2050012-2011-04490, 2050012-2011-04491.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT OBTAINING FIFTEEN (15) ERRONEOUS RESULTS ON A UNICEL DXC 800 PRO SYNCHRON SYSTEM, OVER A 4 DAY PERIOD: (B)(6) 2011. THIS REPORT REPRESENTS THE EVENT THAT OCCURRED ON (B)(6) 2011, WHERE SEVEN (7) PATIENT SAMPLES WERE AFFECTED. THE CUSTOMER STATED THAT THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY, AND THERE WAS NO CHANGE TO PATIENT DIAGNOSIS OR TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1