BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 22051580 · Received May 20, 2025

    Report

    Report Number
    1823260-2025-01549
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 30, 2025
    Report Date
    June 6, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS B3 DATE OF EVENT AND D4 LOT NO WERE UPDATED. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. ANALYSIS OF THE SAMPLE IMAGES SUGGESTS A SAMPLE QUALITY ISSUE, AS TINY PARTICLES WERE OBSERVED THAT MAY HAVE BEEN INCLUDED IN THE REACTION. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT, BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGES THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 18.7 NG/L. THE REPEAT RESULTS WERE 13.7 NG/L, 10.5 NG/L, 10 NG/L, AND 10.9 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191342 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 811848

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown