BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2152699 · Received July 7, 2011

    Report

    Report Number
    1628664-2011-00525
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4), (B)(6) TEST RESULTS. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO INSPECT THE ANALYZER. THE SYRINGE 12 & 13 ICT SUCTION SYRINGES WERE REPLACED. THE FSE INSPECTED THE 3 WAY ICT VALVE, O-RINGS, & ICT PROBES. THE SAMPLE O-RINGS WERE REPLACED. THE SAMPLE AND REAGENT 1 PROBES WERE CALIBRATED. THE FSE REPLACED THE ICT ASPIRATION PUMP WITH NEW PINCH VALVE ASSEMBLY. A PRECISION RUN WAS PERFORMED AND ALL THE RESULTS WERE WITHIN ACCEPTABLE RANGES. A REVIEW OF COMPLAINTS AND QUALITY METRICS DID NOT IDENTIFY AN ADVERSE TREND IN CONJUNCTION WITH POTASSIUM FLYERS. A SERVICE HISTORY REVIEW FROM (B)(4) 2010 THROUGH (B)(4) 2011 DID NOT IDENTIFY ANY PREVIOUS INCIDENTS OF THE ARCHITECT C8000, SERIAL NUMBER (B)(4), GENERATING DISCREPANT RESULTS. NO ADDITIONAL OCCURRENCES OF ERRATIC RESULTS HAVE BEEN DOCUMENTED SINCE THE OPENING OF THIS COMPLAINT. THE ARCHITECT SYSTEM OPERATIONS MANUAL DOES ADDRESS OPERATIONAL PRECAUTIONS, LIMITATIONS, AND ERRATIC RESULTS INCLUDING PROBABLE CAUSES AND CORRECTIVE ACTIONS. IN THE CLINICAL CHEMISTRY INTEGRATE CHIP TECHNOLOGY (ICT) (NA+, K+, CL-) REAGENT PACKAGE INSERT, LITERATURE IS PROVIDED IN DESCRIBING SUITABLE SPECIMENS, RESULTS, AND LIMITATIONS OF THE PROCEDURE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS FOUND. AFTER THE FSE REPLACED THE ICT ASPIRATION PUMP ALONG WITH THE ADDITIONAL INSTRUMENT TROUBLESHOOTING, THE ANALYZER RETURNED TO RUNNING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAD FALSELY ELEVATED POTASSIUM RESULTS ON THE ARCHITECT C8000. A PATIENT SAMPLE HAD A RESULT OF 7.93 MMOL/L AND UPON RE-TEST WAS 4.32 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT POTASSIUM