BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 23979022 · Received January 6, 2026

    Report

    Report Number
    1823260-2026-00062
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    November 13, 2025
    Report Date
    February 23, 2026
    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 QC WAS WITHIN RANGE. THERE WERE NO SAMPLE QUALITY-RELATED ALARMS. THE INVESTIGATION NOTED A GENERAL SUB-OPTIMAL PATIENT SAMPLE QUALITY AT THE CUSTOMER SITE. THE PROVIDED DATA DO NOT INDICATE AN ISSUE WITH THE ANALYZER OR THE REAGENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH A PREANALYTIC (SUB-OPTIMAL PATIENT SAMPLE QUALITY) ISSUE AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 8 PATIENTS' SAMPLES TESTED WITH ELECSYS TROPONIN T HS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 166 NG/L. REPEAT RESULT: 64.0 NG/L. ON (B)(6) 2025: SAMPLE 2: INITIAL RESULT: 25.7 NG/L. 1ST REPEAT RESULT: 20.6 NG/L. 2ND REPEAT RESULT: 20.7 NG/L. ON (B)(6) 2025: SAMPLE 3: INITIAL RESULT: 36.6 NG/L. 1ST REPEAT RESULT: 25.2 NG/L. 2ND REPEAT RESULT: 25.6 NG/L. SAMPLE 4: INITIAL RESULT: 73.1 NG/L. REPEAT RESULT: 60.8 NG/L. ON (B)(6) 2025: SAMPLE 5: INITIAL RESULT: 17.5 NG/L. 1ST REPEAT RESULT: 10.6 NG/L. 2ND REPEAT RESULT: 8.78 NG/L. ON (B)(6) 2025: SAMPLE 6: INITIAL RESULT: 16.4 NG/L. 1ST REPEAT RESULT: 12.6 NG/L. 2ND REPEAT RESULT: 11.9 NG/L. ON (B)(6) 2025: SAMPLE 7: INITIAL RESULT: 16.9 NG/L. REPEAT RESULT: 13.8 NG/L. SAMPLE 8: INITIAL RESULT: 36.9 NG/L. REPEAT RESULT: 46.9 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33512 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 84737601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown