BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2220688 · Received August 23, 2011

    Report

    Report Number
    1628664-2011-00582
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 20, 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 SAMPLE GENERATED AN INITIAL SODIUM ASSAY RESULT OF 116 MMOL/L ON A HEMOLYZED SAMPLE ON THE ARCHITECT C8000, (B)(4). THE SAME SAMPLE WAS THEN TESTED ON ARCHITECT C8000, (B)(4), AND GENERATED SODIUM ASSAY RESULTS OF 138/139/139 MMOL/L. CONTROLS WERE WITHIN SPECIFICATIONS ON ALL RUNS ABOVE; HOWEVER, ALL CONTROLS DID GO OUT OF SPECIFICATIONS ABOUT THREE HOURS LATER ON (B)(4). THERE IS NO IMPACT TO PATIENT MANAGEMENT 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