BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1971938 · Received January 27, 2011

    Report

    Report Number
    1628664-2011-00056
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    MMI
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW OF THE CUSTOMER'S INSTRUMENT SERVICE HISTORY, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. NO ADDITIONAL RELATED COMPLAINTS WERE IDENTIFIED FOR THE CUSTOMER'S INSTRUMENT. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSE POSITIVE TROPONIN RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED AN INITIAL TROPONIN RESULT OF 0.834 NG/ML. UPON REPEAT, TROPONIN RESULTS OF 0.020, 0.018 AND 0.023 NG/ML WERE GENERATED. ANOTHER TUBE FROM THE SAME PATIENT WAS ANALYZED AND TROPONIN RESULTS OF 0.019 AND 0.025 NG/ML WERE GENERATED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER MMI ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1