BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2448924 · Received February 13, 2012

    Report

    Report Number
    2050012-2012-00473
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - RESULTS: WASH COLLAR. THIS REPORT IS ONE OF TWO REPORTS RELATED TO TWO REPORTABLE EVENTS THAT OCCURRED ON TWO DIFFERENT DAYS. THIS REPORT IS RELATED TO MDR#2050012-2012-00474.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600 SYNCHRON SYSTEM GENERATED RANDOM SUPPRESSED PATIENT RESULTS WITH BLANK ABSORBANCE HIGH / LOW ERRORS ON BLOOD UREA NITROGEN (BUN), ASPARTATE AMINOTRANSFERASE (AST) AND TRIGLYCERIDE (TG). CUSTOMER REPORTED THAT THERE WAS A LEAK FROM REAGENT PROBE B. 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) REPLACED THE CARTRIDGE CHEMISTRY SAMPLE PROBE, REAGENT PROBE B, T-VALVE ASSEMBLY ON REAGENT PROBES, COLLAR WASH, REAGENT A/B VALVE AND REAGENT PROBE B 2-WAY VALVE ON MANIFOLD. THE FSE PERFORMED ALIGNMENTS. THE FSE UNLOADED AND RELOADED ALL REAGENTS.

    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. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR