BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 24472055 · Received February 27, 2026

    Report

    Report Number
    3005094123-2026-00100
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 17, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740118075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3P25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98, WITH 510K NUMBER K191595.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TROPONIN RESULTS GENERATED ON AN ARCHITECT I2000SR ANALYZER, (B)(6) FOR A 58-YEAR-OLD PATIENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND REFERRED TO CARDIOLOGY. NO REASON COULD BE FOUND FOR THE HIGH TROPONIN RESULTS. THE FOLLOWING RESULTS WERE PROVIDED (CUTOFF <34 NG/L): SID: (B)(6): (B)(6), (B)(6) 2026 TROPONIN I RESULTS = 298 NG/L AND 296 NG/L. SID: (B)(6): (B)(6), (B)(6) 2026 TROPONIN I = 314 NG/L AND 321 NG/L ROCHE TNT <16 (NORMAL). HISTORICAL RESULTS FOR THE PATIENT RUN ON (B)(6): (B)(6) 2023 TROPONIN I RESULTS = 276 NG/L, 276 NG/L, 257 NG/L, (B)(6) 2023 TROPONIN I RESULT = 234 NG/L, (B)(6) 2023 TROPONIN I RESULT = 249 NG/L, (B)(6) 2025 TROPONIN I RESULT = 324 NG/L, (B)(6) 2025 TROPONIN I RESULT = 308 NG/L, (B)(6) 2025 TROPONIN I RESULT = 295 NG/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92647 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 83089UD00 00380740118075

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6)