BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 24831893 · Received April 9, 2026

    Report

    Report Number
    3005094123-2026-00173
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 28, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740118099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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 PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS 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 A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED FOR A 79-YEAR-OLD MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2026 SAMPLE ID (B)(6) INITIAL RESULT = 176 PG/ML, REPEAT RESULT = 10 PG/ML, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6)= 5 PG/ML. SAME PATIENT NEW SAMPLE OBTAINED. SAMPLE ID (B)(6) RESULT ON (B)(6) = <4 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893153 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 82350UD00 00380740118099

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male ARC I2000SR INST, 03M74-02, (B)(6).