BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 23831840 · Received December 17, 2025

    Report

    Report Number
    3005094123-2025-00651
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 24, 2025
    Report Date
    February 26, 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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), AND A 510K NUMBER OF K191595.

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT WITH UNKNOWN LOT NUMBER, TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY ELEVATED RESULTS. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY USING WORLDWIDE DATA. THE REVIEW PERFORMED INDICATES THAT THE ON-MARKET LOTS ARE COMPARABLE AND PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS. THE CUSTOMER STATED THERE WERE INCIDENCES WERE THE TROPONIN I RESULTS WERE POSITIVE AND WHEN THE PATIENT WAS RECOLLECTED AND NEW SAMPLE WAS NEGATIVE; HOWEVER, NO SPECIFIC PATIENT DATA WAS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS. THE CUSTOMER STATED THERE WERE INCIDENCES WERE THE TROPONIN I RESULTS WERE POSITIVE AND WHEN THE PATIENT WAS RECOLLECTED AND NEW SAMPLE WAS NEGATIVE; HOWEVER, NO SPECIFIC PATIENT DATA WAS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274651 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740118068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2K PROC MOD, 03M74-01, (B)(6).