BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 6519847 · Received April 25, 2017

    Report

    Report Number
    1628664-2017-00146
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    November 17, 2016
    Report Date
    September 6, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DETAILS REGARDING TROUBLESHOOTING ARE PROVIDED BELOW IN THE UPDATED EVALUATION SUMMARY: INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED INSTRUMENT INSPECTION, A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS AND A REVIEW OF LABELING. INSTRUMENT TROUBLESHOOTING INCLUDED A REVIEW OF THE C803178 RESULT LOG WHICH VERIFIED THAT THE QUESTIONED PATIENT RESULT WAS FLAGGED LESS THAN BUT NO ADDITIONAL FLAGS OR INSTRUMENT ERROR MESSAGES WERE NOTED. ADDITIONALLY, SERVICE PERFORMED AN INSTRUMENT INSPECTION WITH NO ADDITIONAL ISSUES NOTED. THE CUSTOMER NOTED THAT THE PERFORMED PREVENTIVE MAINTENANCE RESOLVED THE ISSUE AS NO FURTHER DISCREPANT RESULTS WERE OBSERVED FOLLOWING THIS ACTIVITY. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE AS THE PATIENT RESULT FLAGS LESS THAN AND GREATER THAN INDICATES THE RESULT IS OUTSIDE THE DYNAMIC OR LINEAR RANGE AND THAT THE RESULT MAY NEED FURTHER REVIEW. A REVIEW OF TRACKING AND TRENDING SHOWED NO ADVERSE TREND FOR THE CUSTOMER'S ISSUE. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY DEPRESSED AMMONIA RESULTS ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: (B)(6): INITIAL AMMONIA LESS THAN 21, REPEAT 46. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299217 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1