BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2800416 · Received October 22, 2012

    Report

    Report Number
    1415939-2012-02044
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 79248UN12 WITH A PANEL OF SAMPLES OF KNOWN TROPONIN-I CONCENTRATION. ACCEPTANCE CRITERIA WERE MET, INDICATING ACCEPTABLE PRODUCT PERFORMANCE PER SPECIFICATIONS. A REVIEW OF COMPLAINT TRACKING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. A REVIEW OF TICKET TRENDING AND LOT SEARCH DATA IDENTIFIED ATYPICAL COMPLAINT ACTIVITY RELATED TO DISCREPANT PATIENT RESULTS. ADDITIONALLY, A REVIEW OF CUSTOMER DATA LOGS IDENTIFIED THE CALIBRATION IN USE AT THE TIME OF THE DISCREPANT RESULTS WAS BEYOND THE 30 DAY CURVE STABILITY. SINCE THE CALIBRATION WAS BEYOND THE 30 DAY CURVE STABILITY THIS INDICATES IMPROPER HANDLING OF THE ASSAY. THE ARCHITECT STAT TROPONIN-I ASSAY PACKAGE INSERT AS WELL AS THE ARCHITECT SYSTEM OPERATION MANUAL CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. THE RESULTS OF THE CURRENT ACTIVITY IN CONJUNCTION WITH A REVIEW OF THE CUSTOMER DATA DOES NOT REASONABLY SUGGEST THAT A DEVICE MALFUNCTION CAUSED THE DISCREPANT RESULTS AND SUGGESTS THAT THE DEVICE IS PERFORMING AS INTENDED WHEN USED PER LABELING. NO ADDITIONAL ISSUES WERE IDENTIFIED. CATALOG # FROM 02K41-20 TO 02K41-28.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I ASSAY RESULT OF 0.68 UG/L FOR ONE PATIENT'S SERUM SAMPLE. THE SAMPLE RETESTED AT 0.027 AND 0.027 UG/L. A SECOND SAMPLE (HEPARIN) WAS ALSO COLLECTED AND GENERATED A RESULT OF 0.043 UG/L (SAMPLE IDENTIFICATION OF (B)(6) HEPARINE). THE CUSTOMER USES A CUT-OFF VALUE OF 0.3 UG/L. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 79248UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC I200SR LN: 03M74-02 SN: (B)(4)| ARC I200SR LN: 03M74-02 SN: (B)(4)