BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2040416 · Received April 5, 2011

    Report

    Report Number
    1628664-2011-00141
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW OF THE ANALYZER'S SYSTEM LOGS AND SERVICE HISTORY, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE RESULTS ASSOCIATED WITH THE SAMPLE RUNS IN QUESTION WERE LOCATED IN THE RESULT LOG AND VERIFIED. NO ERRORS WERE GENERATED. NO OTHER SERVICE COMPLAINTS WERE FOUND FOR THE ANALYZER BETWEEN (B)(4) 2011. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. A SINGLE DEFINITIVE CAUSE FOR THE DISCREPANT TROPONIN RESULT WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY IN THE SYSTEM WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSELY ELEVATED TROPONIN RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT GENERATED AN INITIAL TROPONIN RESULT OF 0.345 NG/ML AND REPEAT TROPONIN RESULTS OF 0.003 AND 0.004 NG/ML. THE PATIENT HAD A GENERATED A TROPONIN RESULT OF 0.006 NG/ML THE EVENING PRIOR. THE FALSELY ELEVATED TROPONIN RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND 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 JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1