BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 25298837 · Received May 27, 2026

    Report

    Report Number
    3005094123-2026-00250
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 18, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740165086
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3P25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98, 510K K191595.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TROPONIN RESULT GENERATED ON AN ARCHITECT I2000SR ANALYZER FOR A TWO-MONTH-OLD INFANT. SID 9001 INITIAL RESULT = 317.5 PG/ML, REPEAT RESULT = 322.3 PG/ML. AFTER PEG TREATMENT, THE RESULT WAS 4 PG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289624 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 85654UD01 00380740165086

    Patients

    Seq Age Sex Outcome Treatment
    1