BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2171227 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02554
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    January 5, 2010
    Report Date
    January 5, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE SITE AND PERFORMED TROUBLESHOOTING. THE FSE CLEANED THE ISE FLOW CELL AND REPLACED SEVERAL HARDWARE COMPONENTS. THE CUSTOMER WAS GIVEN THE TWICE-WEEKLY FLOW CELL MAINTENANCE PROCEDURE. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. THIS IS ONE OF FOUR SEPARATE MEDWATCH REPORTS RELATED TO THIS EVENT. ALL ASSOCIATED REPORTS ARE LISTED BELOW: 2050012-2010-00015, 2050012-2011-02550, 2050012-2011-02553. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED FROM JANUARY 1, 2008 THROUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    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 600 INSTRUMENT AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM IS CALIBRATED AND THE QC (QUALITY CONTROL) RUNS ARE PERFORMED ROUTINELY EVERY 8 HOURS. PRIOR TO THE EVENT, THE ISE SYSTEM WAS CALIBRATED AND QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. WHEN A PHYSICIAN QUESTIONED THE LOW RESULTS, THE CUSTOMER RE-RAN THE PATIENT SAMPLES, FOUND THE RESULTS WERE HIGHER AND ISSUED AMENDED REPORTS. THE LAB WAS USING THE AUTOMATED WEEKLY FLOW CELL CLEANING PROCEDURE. THE CUSTOMER PROVIDED FOUR EXAMPLES OF THE ERRONEOUSLY LOW NA RESULTS ALONG WITH THE CORRECTED RESULTS. THE TOTAL NUMBER OF PATIENT SAMPLE RESULTS REPORTED OUT OF THE LABORATORY IS UNKNOWN. WHILE THE CUSTOMER DID NOT RECEIVE ANY REPORT OF ANY ADVERSE EVENT OR PATIENT INJURY ASSOCIATED WITH THIS EVENT, IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR