BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2320186 · Received November 2, 2011

    Report

    Report Number
    2050012-2011-07017
    Event Type
    Malfunction
    Date Received
    November 2, 2011
    Date of Event
    October 3, 2011
    Report Date
    October 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATIONS - METHOD - BEC FIELD SERVICE ENGINEER (FSE) SPOKE TO THE CUSTOMER AND CONFIRMED THE REPAIR PERFORMED BY THE CUSTOMER.(B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED ERRATIC QUALITY CONTROLS ON THE CARTRIDGE CHEMISTRIES (CC). CUSTOMER REPORTED THAT THEY FOUND BUBBLE AND BROWN DISCOLORATION IN THE CC SAMPLE SYRINGE AND REPLACED THE SYRINGE. CUSTOMER REPORTED THAT THEY ALSO FOUND A CRACK IN LINE 172 (LINE 172 DELIVERED WATER). CUSTOMER REPORTED THAT THEY REPAIRED THE LINE BY REMOVING IT FROM THE VALVE, CUT THE END OF THE LINE AND REATTACHED IT BACK TO THE VALVE. THE CUSTOMER REPORTED THAT THE DXC 600I GENERATED ERRONEOUS CHOL RESULTS ON TWO PATIENT SAMPLES. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE RESULTS WERE AMENDED. CUSTOMER REPORTED THAT PATIENT TREATMENT WAS NOT ALTERED BASED ON THE ERRONEOUS RESULT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1