BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 16283311 · Received February 2, 2023

    Report

    Report Number
    1823260-2023-00317
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 12, 2021
    Report Date
    February 2, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE JOURNAL ARTICLE IS "THE UNDERESTIMATED ISSUE OF NON-REPRODUCIBLE CARDIAC TROPONIN I AND T RESULTS: CASE SERIES AND SYSTEMATIC REVIEW OF THE LITERATURE" BY JULIEN FAVRESSE*, JEAN-LOUIS BAYART, DAMIEN GRUSON, SERGIO BERNARDINI, ALDO CLERICO, AND MARCO PERRONE. CLIN CHEM LAB MED 2021; 59(7): 1201¿1211.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF AN UNDERESTIMATION OF NON-REPRODUCIBLE CARDIAC TROPONIN T RESULTS FROM A JOURNAL ARTICLE. IN MAY-2019: CASE REPORT PATIENT 1- THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 102.0 NG/L. THE RESULT OF A 2ND SAMPLE AFTER 5 HOURS WAS 15.1 NG/L. THE REPEAT RESULT OF THE INITIAL SAMPLE WAS 14.4 NG/L. THE REPEAT RESULT OF THE 2ND SAMPLE WAS 14.0 NG/L. IN DEC-2019: CASE REPORT PATIENT 2- THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 84.0 NG/L. THE RESULT OF A 2ND SAMPLE WAS 6.8 NG/L. THE REPEAT RESULT OF THE INITIAL SAMPLE WAS 5.3 NG/L. CASE REPORT PATIENT 3- THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 393.0 NG/L. THE RESULT OF A 2ND SAMPLE AFTER 3 HOURS WAS 10.3 NG/L. THE REPEAT RESULT OF THE INITIAL SAMPLE WAS 12.0 NG/L. THE REPEAT RESULT OF THE 2ND SAMPLE WAS 13.0 NG/L. IN SEP-2020: CASE REPORT PATIENT 4 - THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 42.3 NG/L. THE RESULT OF A 2ND SAMPLE AFTER 4 HOURS WAS 10.8 NG/L. THE REPEAT RESULT OF THE INITIAL SAMPLE WAS 11.8 NG/L. THE REPEAT RESULT OF THE 2ND SAMPLE WAS 12.0 NG/L. THE ARTICLE IS ATTACHED TO THIS REPORT. THE REAGENT LOT NUMBER AND THE EXPIRATION DATE USED WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372183 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female CASE REPORT PATIENT 4: CICLOSPORIN