BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 25220119 · Received May 19, 2026

    Report

    Report Number
    3005094123-2026-00236
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740165093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03P25, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02R98, TROPONIN-I STAT HIGH SENSITIVITY, WITH 510K/PMA/BLA NUMBER K191595.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I FOR TWO PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE =0.0342 NG/ML): (B)(6) 2026, SID (B)(6), 52 YEAR OLD MALE, INITIAL TROPONIN RESULT= 1.5598 NG/ML; REPEAT RESULT= 0.0020 NG/ML, 0.0022 NG/ML (B)(6) 2026, SID (B)(6), 77 YEAR OLD MALE, INITIAL TROPONIN RESULT= 0.6424 NG/ML; REPEAT RESULT= 0.0046 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174444 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 82349UD01 00380740165093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, ISR61756