BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1981801 · Received February 8, 2011

    Report

    Report Number
    1628664-2011-00063
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) VISITED THE CUSTOMER SITE AND PERFORMED ROUTINE INSTRUMENT TROUBLESHOOTING AND COMPONENT REPLACEMENT, RETURNING THE SYSTEM TO WITHIN SPECIFICATIONS. THE ISSUE WAS RESOLVED BY REPLACING THE WORN 1.0 ML SYRINGES FOR THE INTEGRATED CHIP TECHNOLOGY (ICT) ASPIRATION PUMP DUE TO SALT BUILDUP UNDER THE PLUNGER. THE ICT PROBE WAS ALSO CLEANED AND THE CUVETTE DRYER TIPS WERE REALIGNED. A PRECISION RUN WAS PERFORMED ON THE ICT MODULE AND RESULTS WERE WITHIN SPECIFICATIONS. THE ASSAYS WERE CALIBRATED AND ALL CONTROLS WERE RUN WITH ACCEPTABLE RESULTS GENERATED. THE ARCHITECT SYSTEM OPERATIONS MANUAL (LIST NUMBER 201837-108) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER NOTES THAT ERRATIC RESULTS FOR THE ICT MODULE ASSAYS HAVE BEEN OCCURRING SINCE A NEW ICT MODULE WAS INSTALLED ON (B)(4) 2011 ON THE ARCHITECT C8000 ANALYZER. THE CUSTOMER GAVE THE FOLLOWING EXAMPLE: (B)(6), SODIUM: 116, POTASSIUM: 3.9, CHLORIDE (MMOL/L): 94; RETEST: 137, 4.6, 105. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. THE CUSTOMER REMOVED THE ICT MODULE AND REMOVED, CLEANED AND REINSTALLED THE O-RINGS. THE CUSTOMER NOTICED A BUILD-UP OF DRIED BUFFER SALTS ON THE FITTING TO THE TOP OF THE MODULE, INDICATIVE OF A LOOSE CONNECTION. THE CUSTOMER CLEANED THE FITTING AND CONNECTED THE TUBING CORRECTLY (NOT OVERTIGHT). THE CUSTOMER THEN RAN A PRECISION RUN WITH "EXCELLENT" RESULTS. THE CUSTOMER VERIFIED THAT THEY HAD NO FURTHER ERRATIC ICT MODULE ASSAY RESULTS SINCE CORRECTING THE TUBING CONNECTION. HOWEVER, THIS DID NOT RESOLVE THE ISSUE AND A SERVICE CALL WAS INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JGS ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE LN: 9D28-03 (B)(4)| ICT MODULE LN: 9D28-03 (B)(4)