BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 21428042 · Received February 20, 2025

    Report

    Report Number
    3005094123-2025-00085
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 30, 2025
    Report Date
    March 31, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740118075
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT STAT HIGH SENSITIVE TROPONIN-I, LIST NUMBER 03P25-27, AND LONGFORD TO ARCHITECT I1000SR PROCESSING MODULE, LIST NUMBER 01L86-01, AND IRVING. MDR NUMBER 3016438761-2025-00201-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION E1 - PHONE COMPLETE ENTRY = (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03P25, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02R98, AND A 510K/PMA/BLA NUMBER OF K191595.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6), INITIAL RESULT WAS 179.6 PG/ML, WHICH WAS QUESTIONED BY THE PHYSICIAN, REPEAT RESULT WAS <1.9 PG/ML SAMPLE ID (B)(6), INITIAL RESULT WAS 52.2, REPEAT RESULT WAS <1.9 PG/ML. 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 FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT WAS 179.6 PG/ML, WHICH WAS QUESTIONED BY THE PHYSICIAN, REPEAT RESULT WAS <1.9 PG/ML. SAMPLE ID (B)(6) INITIAL RESULT WAS 52.2, REPEAT RESULT WAS <1.9 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464895 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 71169UD00 00380740118075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I1000SR MOD, 01L86-01, (B)(6)| ARC I1000SR MOD, 01L86-01, (B)(6)