BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 25086564 · Received May 5, 2026

    Report

    Report Number
    3005094123-2026-00210
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    January 1, 2025
    Report Date
    May 5, 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 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98, WITH 510K/PMA/BLA NUMBER K191595.

    Description of Event or Problem · 0

    A CONFERENCE ABSTRACT BY C. REILLY, L. DOORLEY, T. PRENDIVILLE, AND JJ BRADY, ¿AN UNUSUAL CASE OF ELEVATED TROPONIN¿, CLINICAL CHEMISTRY AND LABORATORY MEDICINE. 2026; 64(4):EA87-EA88. DOI: 10.1515/CCLM-2026-0148., DOCUMENTED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR AN 8 YEAR OLD BOY WITH PALPITATIONS AND CHEST PAIN. THE CONFERENCE ABSTRACT NOTED AN 8-YEAR-OLD BOY WHO WAS EVALUATED AT HIS LOCAL HOSPITAL FOR EPISODES OF PALPITATIONS AND CHEST PAIN. THE WORKING DIAGNOSIS WAS MYOPERICARDITIS. HIS ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS RANGED FROM 20 TO 106 NG/L FROM THE INITIAL ADMISSION AND FOLLOW UP OVER A 2-MONTH PERIOD. THE SIEMENS ATELLICA ANALYZER RESULTS RANGED FROM 26.7 TO 829 NG/L OVER A 3-MONTH PERIOD. HIS TROPONIN VALUE ROSE TO 487 NG/L DESPITE NORMAL CARDIAC EXAMINATION AND CLINICAL FINDINGS. THE SAMPLE WAS REPEATED WITH TROPONIN-T ON A ROCHE ANALYZER WHICH GENERATED A NORMAL RESULT OF <14 NG/L. THE SAMPLE DIDN¿T DILUTE LINEARLY, AND PEG PRECIPITATION HAD A RECOVERY OF 11.7%. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448005 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740118075

    Patients

    Seq Age Sex Outcome Treatment
    1