BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 24815979 · Received April 8, 2026

    Report

    Report Number
    3005094123-2026-00168
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740165093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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, WITH 510K/PMA/BLA NUMBER K191595. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I FOR A 51 YEAR OLD MALE. THE SAMPLE WAS REPEATED USING PEG PRECIPITATION WITH LOWER RESULTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE =34.2 PG/ML): SID (B)(6), INITIAL TROPONIN RESULT= 426.99 PG/ML; REPEAT RESULT= 414.01 PG/ML; REPEAT RESULT USING PEG PRECIPITATION= 1.44 PG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881160 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 82349UD01 00380740165093

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male ARC I2000SR INST, 03M74-02, (B)(6.