BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2220689 · Received August 23, 2011

    Report

    Report Number
    1628664-2011-00581
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. NO CONSEQUENCES OR IMPACT TO PATIENT. LOW TEST RESULTS.

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE AND REPLACED THE ENTIRE INTEGRATED CHIP TECHNOLOGY (ICT) ASPIRATION PUMP, WHICH INCLUDES THE ASPIRATION VALVE. THE CUSTOMER'S COMPLAINT HISTORY DOES NOT INCLUDE A RECURRENCE OF ICT RELATED ISSUES SINCE THE ICT ASPIRATION PUMP WAS REPLACED. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL (PN 201837-108, JANUARY, 2010) AND THE ICT SAMPLE DILUENT PACKAGE INSERT (304465/ R1, OCTOBER 2009) BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE AVAILABLE INFORMATION AND THIS EVALUATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT'S INITIAL ARCHITECT C8000 SODIUM ASSAY RESULT OF 102 MMOL/L AND POTASSIUM RESULT OF 2.9 MMOL/L WERE REPORTED FROM THE LAB. THE PATIENT WAS STARED ON IV FLUIDS FOR THE LOW SODIUM RESULT. THE SAMPLE RETESTED WITH A SODIUM RETESTED AT 116 MMOL/L (RESULTS FROM ARCHITECT C8000 SN: C801683). THIS SAME SAMPLE WAS THEN TESTED ON THE ARCHITECT C8000 ANALYZER, SN: C801423, ABOUT ONE HOUR LATER WITH SODIUM RESULTS OF 138/137/138 MMOL/L AND POTASSIUM RESULTS OF 4.3/4.9 MMOL/L. THE IV FLUIDS WERE DISCONTINUED. A NEW SAMPLE TAKEN THE FOLLOWING DAY GENERATED A SODIUM RESULT OF 137 MMOL/L AND A POTASSIUM RESULT OF 4.9 MMOL/L. CONTROLS WERE WITHIN SPECIFICATIONS AT THE TIME OF THE ABOVE RUNS; HOWEVER, ALL CONTROLS DID GO OUT OF SPECIFICATIONS ABOUT THREE HOURS LATER ON SN C801683. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT DUE TO THE IV TREATMENT. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED. A SERVICE CALL WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM JGS ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AERO/C8K ICT MODULE LN: 9D28-03| AERO/C8K ICT MODULE LN: 9D28-03