BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 24641225 · Received March 19, 2026

    Report

    Report Number
    1823260-2026-01005
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 24, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT EXPIRATION DATES WERE NOT PROVIDED. THE CUSTOMER SUSPECTS AN INTERFERING FACTOR IN THE PATIENT SAMPLES. THE CUSTOMER SENT A SAMPLE COLLECTED ON (B)(6) 2026 TO ANOTHER LABORATORY AND STATED THAT MACRO TROPONIN WAS DETECTED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE MEDWATCH SECTION D, DEVICE IDENTIFICATION WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE CUSTOMER INDEPENDENTLY PERFORMED AN ANALYSIS THAT YIELDED A POSITIVE RESULT FOR MACROTROPONIN. THE INVESTIGATION DETERMINED THAT THE FINDINGS OF MACROTROPONIN IN THE PATIENT'S SAMPLE ARE MOST LIKELY RESPONSIBLE FOR THE ELEVATED TNT RESULT. PER PRODUCT LABELING, "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN." THE INVESTIGATION DETERMINED THAT THERE WAS NO PRODUCT PROBLEM FOUND.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TROPONIN T RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2026, THE PATIENT HAD THREE SEPARATE SAMPLES COLLECTED. THE SEPARATE SAMPLE RESULTS WERE 43 NG/L, 39 NG/L, AND 39 NG/L PRODUCED FROM REAGENT LOT 847376. ON (B)(6) 2026, THE PATIENT HAD NEW SAMPLE RESULT OF 42 NG/L PRODUCED FROM REAGENT LOT 847376. ON (B)(6) 2026, THE PATIENT HAD A NEW SAMPLE RESULT OF 42 NG/L PRODUCED FROM REAGENT LOT 847376. ON (B)(6) 2026, THE PATIENT HAD A NEW SAMPLE RESULT OF 44 NG/L PRODUCED FROM REAGENT LOT 882520. THE CUSTOMER ALSO PROVIDED A RESULT OF 47 NG/L FROM THE PATIENT WITHIN THE DATE RANGE OF (B)(6) 2026. THE SPECIFIC DATE OF TESTING WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703860 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS E801 847376, 882520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown LEPONEX.