BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 24551616 · Received March 9, 2026

    Report

    Report Number
    3005094123-2026-00115
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    October 7, 2025
    Report Date
    May 5, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740118068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3P25, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98, AND A 510K/PMA/BLA NUMBER K191595.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TROPONIN I RESULTS GENERATED ON AN ARCHITECT I2000 PROCESSING MODULE FOR A 65-YEAR-OLD HEALTHY FEMALE PATIENT WHEN COMPARED TO TROPONIN T. THE FOLLOWING DATA WAS PROVIDED: BEFORE (B)(6) 2025: ALINITY TROPONIN = >80 PG/ML AT (B)(6). (B)(6) 2025 PATIENT WAS REFERRED TO (B)(6) HOSPITAL. TROPONIN I RESULT = 58.91 PG/ML. (B)(6) 2025 TROPONIN I RESULT = 81.14 PG/ML. (B)(6) 2026 TROPONIN I RESULT = 126.6 PG/ML. (B)(6) 2026 TROPONIN T RESULT = 0.007 NG/ML (REFERENCE VALUE </= 0.014 NG/ML), CKMB = 12, CK = 105. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243740 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740118068

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female ARC I2K PROC MOD, 03M74-01, ISR54635.