BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 24500729 · Received March 3, 2026

    Report

    Report Number
    3005094123-2026-00103
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 18, 2026
    Report Date
    May 7, 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

    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 3P25 (ARCHITECT TROPONIN-I, STAT HIGH SENSITIVE) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98 (ARCHITECT TROPONIN-I STAT HIGH SENSITIVITY), WITH 510K/PMA/BLA NUMBER K191595.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I AND PROVIDED THE FOLLOWING DATA FOR A 68-YEAR-OLD MALE PATIENT WHO PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2026. THE CUSTOMER PROVIDED THE FOLLOWING LABORATORY DATA: CUSTOMER CUT OFF FOR MALE IS <34NG/L. ON (B)(6) 2026: SAMPLE ID (B)(6) RESULT WAS 139 NG/L ON SN: (B)(6), SAMPLE ID (B)(6) RESULT WAS 138 NG/L ON SN: (B)(6), SAMPLE ID (B)(6) RESULT WAS 133 NG/L ON SN: (B)(6). ON (B)(6) 2026: SAMPLE ID (B)(6) RESULT WAS 138 NG/L ON SN: (B)(6). ON (B)(6) 2026: SAMPLE ID (B)(6) RESULT WAS 133 NG/L ON SN: (B)(6). ON (B)(6) 2026: SAMPLE ID (B)(6) RESULT WAS 125 NG/L ON SN: (B)(6). SAMPLE ID (B)(6) RESULT WAS 132 NG/L ON SN: (B)(6). THE CUSTOMER REPORTED THAT A SAMPLE WAS SENT TO A REFERENCE LAB AND THE TROPONIN T RESULT WAS <14. THE CUSTOMER REPORTED THAT THEY DON'T HAVE ANY FURTHER CLINICAL DETAILS FOR THE PATIENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205822 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 83089UD00 00380740118075

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male ARC I2K PROC MOD, 03M74-01, (B)(6).| ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6),