BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2664315 · Received July 22, 2012

    Report

    Report Number
    2050012-2012-01390
    Event Type
    Malfunction
    Date Received
    July 22, 2012
    Date of Event
    June 27, 2012
    Report Date
    June 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT SODIUM (NA) VALUES DROPPED AFTER MAINTENANCE OF THE UNICEL DXC 600 SYNCHRON SYSTEM (DXC 600). CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THEY SENT OUT AMENDED REPORTS FOR SODIUM AND POTASSIUM. CUSTOMER REPORTED THAT THEY HAD RUN ABOUT 12 TO 15 SAMPLES WHERE THE SODIUM AND POTASSIUM HAD DROPPED. CUSTOMER REPORTED THAT CHLORIDE AND CALCIUM WERE ACCEPTABLE. CUSTOMER REPORTED THAT QUALITY CONTROL (QC) RAN BEFORE THE EVENT WAS IN RANGE BUT ON THE LOW SIDE FOR SODIUM. CUSTOMER REPORTED THAT TWICE WEEKLY MAINTENANCE WAS LAST PERFORMED ON (B)(6) AT NIGHT. BEC CUSTOMER TECHNICAL SPECIALIST (CTS) INSTRUCTED THE CUSTOMER THEY COULD CALIBRATE AFTER MAINTENANCE WITH A CLEAR PATIENT SAMPLE TO CONDITION THE ELECTRODES AND THEN CALIBRATE WITH AQUA CALIBRATOR AND RUN QUALITY CONTROL (QC). 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 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR