BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 22229403 · Received June 17, 2025

    Report

    Report Number
    1823260-2025-01867
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 25, 2025
    Report Date
    July 16, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). QC AND CALIBRATION WERE IN RANGE BEFORE THE EVENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    PATIENT 2'S INITIAL RESULT ON 07-JUN-2025 WAS 15.8 NG/L. THE FIRST REPEAT RESULT WAS 8.60 NG/L. THE SECOND REPEAT RESULT WAS 9.19 NG/L AND WAS REPORTED OUT. PATIENT 3'S INITIAL RESULT ON 09-JUN-2025 WAS 36.9 NG/L. THE FIRST REPEAT RESULT WAS 29.4 NG/L. THE SECOND REPEAT RESULT WAS 29.4 NG/L AND WAS REPORTED OUT. PATIENT 4'S INITIAL RESULT ON 14-JUN-2025 WAS 18.4 NG/L. THE FIRST REPEAT RESULT WAS 13.9 NG/L. THE SECOND REPEAT RESULT WAS 14.0 NG/L.

    Additional Manufacturer Narrative · 0

    PATIENT 5'S INITIAL RESULT ON (B)(6) 2025 WAS 14.4 NG/L THE FIRST REPEAT RESULT WAS 19.6 NG/L. THE SECOND REPEAT RESULT WAS 14.2 NG/L. PATIENT 6'S INITIAL RESULT ON (B)(6) 2025 WAS 9.71 NG/L. THE FIRST REPEAT RESULT WAS 6.43 NG/L. THE SECOND REPEAT RESULT WAS 6.89 NG/L. THE REAGENT LOT NUMBER USED FOR PATIENTS 5 AND 6 IS 827232. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT, AS THE QC WAS IN RANGE BEFORE THE EVENT.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS TROPONIN T HS RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 7.34 NG/L, THE FIRST REPEAT RESULT WAS 15.8 NG/L, AND THE 2ND REPEAT RESULT WAS 12.8 NG/L. THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2025, WITH RESULTS OF 7.24 NG/L AND 6.63 NG/L. THE RESULT OF 12.8 NG/L WAS REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103628 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 81184801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown