BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2913955 · Received January 14, 2013

    Report

    Report Number
    1415939-2013-00011
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A PERFORMANCE STUDY, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. AN INTERNAL TROPONIN-I PANEL WAS TESTED WITH REAGENT LOT 17330UN12 AND MET SPECIFICATIONS. TRACKING AND TRENDING IDENTIFIED NO ATYPICAL COMPLAINT ACTIVITY RELATED TO DISCREPANT PATIENT RESULTS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE EVALUATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    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 59.257 NG/L. THE SAMPLE WAS REPEATED AND A TROPONIN RESULT OF 31.938 NG/L WAS GENERATED. THE FALSE POSITIVE 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
    19964 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 17330UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN 03M74-02 SN (B)(4)| ARCHITECT I2000SR ANALYZER| LN 03M74-02 SN (B)(4)