BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 23142191 · Received September 25, 2025

    Report

    Report Number
    1823260-2025-03639
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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). NO CALIBRATION INFLUENCE WAS OBSERVED. THE QC WAS WITHIN RANGE BEFORE THE SAMPLE MEASUREMENTS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    AN INSTRUMENT CONTAMINATION WAS OBSERVED. THE ANALYSIS OF THE SAMPLE FOAM DETECTION (SFD) IMAGES SHOWED THE FOLLOWING: THE ACTIVE GRIPPER WHEELS WERE DIRTY. ONE OF THE SAMPLES (SAMPLE A): A FILM IN THE PIPETTING AREA. ONE OF THE SAMPLES (SAMPLE B): DUST-LIKE PARTICLES FLOATING AT THE SURFACE. ONE OF THE SAMPLES (SAMPLE C): FILM AND TRANSPARENT PARTICLES. A GENERAL REAGENT OR ANALYZER PROBLEM CAN BE EXCLUDED BECAUSE THE QC WAS WITHIN THE RANGES PRIOR TO THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE WAS CONSISTENT WITH A SUBOPTIMAL SAMPLE QUALITY DETECTED IN THE SFD IMAGES.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS TROPONIN T HS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: INITIAL RESULT: 136 NG/L (TESTED ON COBAS 1). THE SAMPLE WAS REPEATED PER THE CARDIAC TROPONIN MONITORING PROTOCOL, AND THE REPEAT RESULTS WERE 10.6 NG/L AND 11 NG/L. BOTH RESULTS WERE INTERPRETED AS NEGATIVE. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND TESTED, RESULTING IN A TROPONIN T HS VALUE OF 7.95 NG/L. PATIENT 2: INITIAL RESULT: 18.8 NG/L (INTERPRETED AS POSITIVE). REPEAT RESULT: 12.8 NG/L (INTERPRETED AS NEGATIVE). THE REPEAT RESULTS FOR PATIENT 1 AND PATIENT 2 WERE DEEMED TO BE CORRECT. PATIENT 3 AND PATIENT 4 WERE TESTED ON (B)(6) 2025: PATIENT 3: INITIAL RESULT: 76.2 NG/L (TESTED ON COBAS 1). 1ST REPEAT RESULT: 127 NG/L (TESTED ON COBAS 3). 2ND REPEAT RESULT: 75.4 NG/L (TESTED ON COBAS 1). 3RD REPEAT RESULT: 65.6 NG/L (TESTED ON COBAS 3). PATIENT 4: INITIAL RESULT: 17.5 NG/L (TESTED ON COBAS 1). 1ST REPEAT RESULT: 48.1 NG/L (TESTED ON COBAS 3). 2ND REPEAT RESULT: 17.0 NG/L (TESTED ON COBAS 1). 3RD REPEAT RESULT: 14.7 NG/L (TESTED ON COBAS 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849444 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 82723202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown