BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1812818 · Received August 24, 2010

    Report

    Report Number
    1415939-2010-00395
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 3, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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). AN INVESTIGATION WAS INITIATED TO FURTHER INVESTIGATE THE CUSTOMER ISSUE INCLUDING A REVIEW OF THE COMPLAINT TEXT, TESTING OF RETURNED MATERIAL AND PANEL TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. PATIENT SAMPLE (B)(6) WAS TESTED UNDILUTED USING A FILE KIT OF THE SAME LOT NUMBER AS THE CUSTOMER'S LOT. AN EXPECTED, NEGATIVE RESULT OF 0.01 NG/ML WAS OBTAINED. AN INTERNAL TROPONIN-I PANEL WAS ALSO TESTED AND RESULTS WERE WITHIN SPECIFICATION. TRACKING AND TRENDING DID NOT INDICATE ANY ADVERSE TREND FOR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR FALSE POSITIVE ARCHITECT TROPONIN-I RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSE POSITIVE TROPONIN RESULT FOR ONE PATIENT SAMPLE. THE SAMPLE GENERATED AN INITIAL TROPONIN RESULT OF 0.661 NG/ML AND A REPEAT TROPONIN RESULT OF 0.000 NG/ML. 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 STAT TROPONIN-I FOR THE DETERMINATION OF CARDIAC TROPONIN-I IN HUMAN SERUM OR PLASMA MMI ABBOTT LABORATORIES 39419UN10

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN 3M74-01 (B)(4)| ARCH I2000SR LN 3M74-01 (B)(4)