BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 3142386 · Received June 3, 2013

    Report

    Report Number
    1415939-2013-00256
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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

    A STUDY WAS PERFORMED TO EVALUATE ASSAY PERFORMANCE. AN INTERNAL TROPONIN-I PANEL WAS TESTED WITH IN-HOUSE STORED ARCHITECT STAT TROPONIN-I REAGENT LOT 06017UN13 (ALL OF THE MATERIALS UTILIZED IN TESTING WERE STORED AND MAINTAINED AT OUR FACILITY). THE TROPONIN-I PANEL IS TARGETED TO A KNOWN CONCENTRATION. THE PANEL WAS WITHIN SPECIFICATION, WHICH DEMONSTRATES THAT THE ASSAY CAN ACCURATELY DETECT A KNOWN CONCENTRATION 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 ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. THE COMPLAINT TEXT INDICATED THAT IT IS UNKNOWN IF THE SAMPLES WERE HANDLED ACCORDING TO THE PACKAGE INSERT. ADDITIONALLY, REPEAT OF THE SAMPLES OR REDRAWS GENERATED NEGATIVE OR LOWER RESULTS. WITH THE INFORMATION FROM THE CUSTOMER SITE AND WITH THE RESULTS OF THE CURRENT EVALUATION, IT IS DEMONSTRATED THAT THE ARCHITECT STAT TROPONIN-I ASSAY, LOT 06017UN13, IS PERFORMING AS EXPECTED. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I ASSAY RESULT FOR ONE FEMALE PATIENT. AN INITIAL RESULT OF 0.156 UG/L WAS GENERATED. THE CUSTOMER USES A CUT-OFF VALUE OF 0.013 UG/L FOR FEMALE PATIENTS. THE SAMPLE WAS IMMEDIATELY RETESTED AND GENERATED AN ELEVATED RESULT OF 0.094 UG/L. THE FOLLOWING MORNING, A NEW SAMPLE WAS DRAWN AND TESTED FROM THIS PATIENT AND GENERATED ARCHITECT STAT TROPONIN-I RESULTS OF 0.000 AND 0.000 UG/L. THE PATIENT'S PHYSICIAN HAD THE INITIAL SAMPLE RETESTED, WHICH GENERATED AN ELEVATED RESULT OF 0.071 UG/L. THE CUSTOMER USES ONLY ONE CONTROL TARGETED AT 7.128 UG/L AND STATED THAT THE CONTROL WAS WITHIN SPECIFICATIONS. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242853 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 06017UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 SN: (B)(4).| ARCHITECT I1000SR LN: 01L86-40