BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 23978932 · Received January 6, 2026

    Report

    Report Number
    1823260-2026-00063
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    November 15, 2025
    Report Date
    February 24, 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 THE RANGE. NO RELEVANT ALARMS OCCURRED. THE CUSTOMER AND SERVICE MAINTENANCE WERE PERFORMED PER THE SPECIFICATIONS. THE INSTRUMENT SURFACES WERE ADEQUATELY CLEAN. THE SAMPLE FOAM DETECTION (SFD) IMAGES FOR SAMPLE 5 SHOWED WHITE PARTICULATE MATTER. THE SFD IMAGES OF THE REST OF THE SAMPLES SHOWED SUB-OPTIMAL SAMPLE QUALITY. THE PROVIDED DATA DID 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 ISSUE AND A SUB-OPTIMAL SAMPLE QUALITY 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 5 PATIENTS' SAMPLES TESTED WITH ELECSYS TROPONIN T HS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 55.9 NG/L. 1ST REPEAT RESULT: 78.4 NG/L. 2ND REPEAT RESULT: 78.7 NG/L. ON (B)(6) 2025: SAMPLE 2: INITIAL RESULT: 4110 NG/L. REPEAT RESULT: 2751 NG/L. ON (B)(6) 2025: SAMPLE 3: INITIAL RESULT: 18.3 NG/L. 1ST REPEAT RESULT: 18.2 NG/L. 2ND REPEAT RESULT: 14.9 NG/L. ON (B)(6) 2025: SAMPLE 4: INITIAL RESULT: 1389 NG/L. 1ST REPEAT RESULT: 1121 NG/L. 2ND REPEAT RESULT: 1349 NG/L. 3RD REPEAT RESULT: "14 SOMETHING" NG/L (THE EXACT VALUE WAS NOT PROVIDED). ON (B)(6) 2025: SAMPLE 5: INITIAL RESULT: 30.7 NG/L. 1ST REPEAT RESULT: 47.3 NG/L. 2ND REPEAT RESULT: 30.6 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490577 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 84737601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown