BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON SYSTEM

    MDR report key: 2169892 · Received July 15, 2011

    Report

    Report Number
    2050012-2011-03016
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    May 12, 2009
    Report Date
    May 12, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K060256
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE SITE SINCE THE CUSTOMER DID NOT REQUEST ONE. THE BCI HOTLINE CUSTOMER SERVICE TECHNICIAN RECOMMENDED THAT THE CUSTOMER CLEAN THE NA ELECTRODES. WHILE THIS MEASURE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE WAS NOT DETERMINED. THIS IS 1 OF 60 INDIVIDUAL MEDWATCH REPORTS WHICH ARE RELATED TO THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED FROM JANUARY 1, 2008 THROUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS. 2050012-2011-01616, 2050012-2011-03011, 2050012-2011-03012, 2050012-2011-03013, 2050012-2011-03014, 2050012-2011-03015, 2050012-2011-03017, 2050012-2011-03018, 2050012-2011-03019, 2050012-2011-03020, 2050012-2011-03021, 2050012-2011-03022, 2050012-2011-03023, 2050012-2011-03024, 2050012-2011-03025, 2050012-2011-03026, 2050012-2011-03027, 2050012-2011-03028, 2050012-2011-03029, 2050012-2011-03030, 2050012-2011-03031, 2050012-2011-03032, 2050012-2011-03033, 2050012-2011-03034, 2050012-2011-03035, 2050012-2011-03036, 2050012-2011-03037, 2050012-2011-03038, 2050012-2011-03039, 2050012-2011-03040, 2050012-2011-03041, 2050012-2011-03042, 2050012-2011-03043, 2050012-2011-03044, 2050012-2011-03045, 2050012-2011-03046, 2050012-2011-03047, 2050012-2011-03048, 2050012-2011-03049, 2050012-2011-03050, 2050012-2011-03051, 2050012-2011-03052, 2050012-2011-03053, 2050012-2011-03054, 2050012-2011-03055, 2050012-2011-03056, 2050012-2011-03057, 2050012-2011-03058, 2050012-2011-03059, 2050012-2011-03060, 2050012-2011-03061, 2050012-2011-03062, 2050012-2011-03063, 2050012-2011-03064, 2050012-2011-03065, 2050012-2011-03066, 2050012-2011-03067, 2050012-2011-03068, 2050012-2011-03069.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 600I SYNCHRON INSTRUMENT AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. PRIOR TO THE EVENT, THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS CALIBRATED AND THE QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. WHEN PHYSICIANS QUESTIONED THE LOW NA RESULTS, THE LAB RE-RAN THE QC AND FOUND THE QC RESULTS TO BE LOW. FOLLOWING INSTRUCTIONS FROM THE BCI HOTLINE SUPPORT, THE CUSTOMER REMOVED AND CLEANED THE NA ELECTRODES AND RECALIBRATED THE ISE SYSTEM. THE QC CONTROLS WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE PATIENT SAMPLES WERE RERUN, THE REPEATED RESULTS WERE FOUND TO BE HIGHER (APPROXIMATELY 3-7 MMOL/L HIGHER), AND THE CUSTOMER AMENDED THE RESULTS AND FILED 60 CORRECTED REPORTS. NO PATIENT OR SAMPLE DATA WAS PROVIDED BY THE CUSTOMER. WHILE THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS ANY CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON SYSTEM JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK