BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2283268 · Received October 7, 2011

    Report

    Report Number
    2050012-2011-06024
    Event Type
    Malfunction
    Date Received
    October 7, 2011
    Date of Event
    September 7, 2011
    Report Date
    September 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER PERFORMED CORRELATION TESTING ON THE TWO UNICEL DXC 600 ANALYZERS WITH FIVE (5) RANDOM SAMPLES. THE DIFFERENCE FOR 2 OF THE 5 RANDOM SAMPLES EXCEEDED THE ANALYZERS' PRECISION CLAIMS. CUSTOMER PROVIDED THE FOLLOWING DATA TO BEC: ID: S/N (B)(4); S/N (B)(4). ID: RANDOM 1; CO2 (MMOL/L): 23; CO2 (MMOL/L): 24. ID: RANDOM 2; CO2 (MMOL/L): 22; CO2 (MMOL/L): 21. ID: RANDOM 3; CO2 (MMOL/L): 17; CO2 (MMOL/L): 17. ID: RANDOM 4**; CO2 (MMOL/L): 29; CO2 (MMOL/L): 25. ID: RANDOM 5**; CO2 (MMOL/L): 22; CO2 (MMOL/L): 26. DIFFERENCE IN RESULTS EXCEEDED THE PRECISION OF THE ANALYZERS. BEC FIELD SERVICE ENGINEER (FSE) FOUND BOTH UNICEL DXC 600 ANALYZERS (S/N (B)(4) AND S/N (B)(4)) HAD IMPRECISION ISSUES. THE FSE REPLACED THE CO2 REFERENCE ELECTRODE ON THE INSTRUMENTS. THIS ACTION IMPROVED PRECISION. THE FSE VERIFIED PERFORMANCE ON BOTH INSTRUMENTS. THIS IS ONE OF TWO REPORTS RELATED TO TWO EVENTS THAT OCCURRED ON THE SAME DAY. THIS MDR IS RELATED TO MDR#2050012-2011-06029.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600 SYNCHRON SYSTEM (SERIAL NUMBER (B)(4)) GENERATED CO2 PATIENT RESULTS THAT DID NOT MATCH THE CUSTOMER'S USUAL RUN. CUSTOMER COMPARED THE CO2 RESULTS GENERATED BY AN ALTERNATE UNICEL DXC 600 SYNCHRON SYSTEM (SERIAL NUMBER (B)(4)) AND NOTICED THAT THE RESULTS VARIED. CUSTOMER REPORTED THAT TO THE BEST OF HER KNOWLEDGE NO ERRONEOUS PATIENT RESULTS WERE REPORTED OR GENERATED. 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. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1