BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 22846718 · Received August 19, 2025

    Report

    Report Number
    3005094123-2025-00403
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    August 3, 2025
    Report Date
    November 5, 2025
    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: NO PATIENT INFORMATION WAS PROVIDED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3P25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98, AND 510K/PMA/BLA OF K191595. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D4 CATALOG # UPDATED AND PRIMARY UDI NUMBER UPDATED. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW OF COMPLAINT DATA FOR THE COMPLAINT LIST NUMBER DOES NOT IDENTIFY ANY INCREASE IN COMPLAINT ACTIVITY. THE LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. A DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES AND DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. A REVIEW OF THE PERFORMANCE OF REAGENT LOT 74189UD00 DETERMINED THAT THIS LOT WAS PERFORMING IN LINE WITH PREVIOUSLY MANUFACTURED REAGENTS. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT IDENTIFIED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT. THE PATIENT TESTED TROPONIN 500 PG/ML (POSITIVE), BUT REPEATED 0.8 PG/ML (NEGATIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT. THE PATIENT TESTED TROPONIN 500 PG/ML (POSITIVE), BUT REPEATED 0.8 PG/ML (NEGATIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243835 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 74189UD01 00380740165093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, ISR63545