BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1982898 · Received February 9, 2011

    Report

    Report Number
    1415939-2011-00028
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE PERFORMANCE OF THE ARCHITECT STAT TROPONIN-I ASSAY WAS EVALUATED BY TESTING AN IN-HOUSE SAMPLE PANEL USING THE SUSPECT REAGENT LOT 42894UN10. THE TROPONIN-I PANEL IS MADE FROM HUMAN PLASMA AND IS TARGETED TO A KNOWN CONCENTRATION. THE PANEL RESULTS WERE WITHIN SPECIFICATION, DEMONSTRATING THAT THE ARCHITECT STAT TROPONIN-I ASSAY CAN ACCURATELY DETECT KNOWN CONCENTRATIONS OF TROPONIN-I. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT STAT TROPONIN-I REAGENT PACKAGE INSERT (REVISION NUMBER (B)(4)) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. THE CURRENT INVESTIGATION DETERMINED THAT THE ARCHITECT STAT TROPONIN-I ASSAY, LOT 42894UN10, IS PERFORMING AS INTENDED AND MEETING SAFETY, EFFECTIVENESS AND LABEL CLAIMS. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. EVALUATION, METHOD: REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT INITIALLY CONTROLS WERE WITHIN SPECIFICATIONS WHEN TESTING SAMPLES WITH THE ARCHITECT STAT TROPONIN-I ASSAY ON THE ARCHITECT I2000SR ANALYZER. EIGHT HOURS LATER, THE MID-RANGE CONTROL WAS OUT OF SPECIFICATION LOW. THE CUSTOMER RECALIBRATED THE ASSAY AND CONTROLS WERE ONCE AGAIN IN SPECIFICATIONS. SAMPLES WERE THEN TESTED OVERNIGHT. IN THE MORNING, CONTROLS WERE OUT OF SPECIFICATION LOW. THE CUSTOMER NOTED THAT THE CALIBRATION CURVE DATA POINTS WERE DIFFERENT BETWEEN THE PREVIOUS TWO CALIBRATION CURVES. A FALSELY ELEVATED PATIENT RESULT WAS REPORTED OUT OF THE LAB. THE SAMPLE INITIALLY TESTED AT 0.184 AND 0.142 NG/ML. THE SAMPLE WAS RETESTED ON ANOTHER ARCHITECT I2000SR ANALYZER IN THE LAB AND GENERATED RESULTS OF 0.027 AND 0.017 NG/ML (THE CUSTOMER USES A CUT-OFF VALUE OF <0.03 NG/ML). THE CUSTOMER RECALIBRATED THE ASSAY WITH A NEW KIT FROM THE SAME LOT AND ALL SAMPLES ARE GENERATING ACCEPTABLE VALUES. THERE IS NO 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 42894UN10

    Patients

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