BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 23595975 · Received November 19, 2025

    Report

    Report Number
    3005094123-2025-00585
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 5, 2025
    Report Date
    January 26, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740118099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 (TROPONIN-I, STAT HIGH SENSITIVE) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98 (TROPONIN-I STAT HIGH SENSITIVITY) WITH 510K/PMA/BLA NUMBER K191595. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 77552UD00. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES WITH THE LOT NUMBER AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT IN THE FIELD WAS REVIEWED USING DATA FROM CUSTOMERS WORLDWIDE. THE REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR THE LOT IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. ADDITIONALLY, PER PRODUCT LABELLING, ANY CONDITION RESULTING IN MYOCARDIAL INJURY CAN POTENTIALLY INCREASE CARDIAC TROPONIN I LEVELS. WHEN AN INCREASED VALUE FOR CTNI IS ENCOUNTERED (E.G., EXCEEDING THE 99TH PERCENTILE OF A REFERENCE CONTROL POPULATION) IN THE ABSENCE OF EVIDENCE OF MYOCARDIAL ISCHEMIA, A CAREFUL SEARCH OF OTHER POSSIBLE ETIOLOGIES FOR CARDIAC DAMAGE SHOULD BE TAKEN. ELEVATED TROPONIN LEVELS MAY BE INDICATIVE OF MYOCARDIAL INJURY ASSOCIATED WITH HEART FAILURE, RENAL FAILURE, CHRONIC RENAL DISEASE, MYOCARDITIS, ARRHYTHMIAS, PULMONARY EMBOLISM, OR OTHER CLINICAL CONDITIONS. SPECIMENS FROM INDIVIDUALS WITH PATHOLOGICALLY HIGH TOTAL PROTEIN MAY DEMONSTRATE ANOMALOUS VALUES. A SINGLE CTNI RESULT MAY NOT BE SUFFICIENT TO EVALUATE MI. SERIAL SAMPLING TO DETECT THE TEMPORAL RISE AND FALL OF CTNI LEVELS IS RECOMMENDED FOR THE DIFFERENTIATION OF ACUTE CARDIAC EVENTS FROM CHRONIC CARDIAC DISEASE. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS. FOR MI DIAGNOSTIC PURPOSES, THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER INFORMATION SUCH AS ECG, CLINICAL OBSERVATIONS, AND SYMPTOMS, ETC. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 77552UD00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR A 43 YEAR OLD MALE PATIENT. THE CUSTOMER MENTIONED THE PATIENT IS A COMPETITIVE BASKETBALL PLAYER AND HAD AN EPISODE OF EXTRASYSTOLE A FEW MONTHS AGO AND IS TAKING 2.5 MG/DAY OF BETAPROLOL (BETA-BLOCKER). THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED EXPECTED VALUES FOR MALE PATIENTS: POSITIVE >/= 34.2 NG/L) (B)(6) 2025 SID (B)(6) RESULTS = 106.1 NG/L, 111.9 NG/L, SAMPLE TESTED WITH TROPONIN I BECKMAN AND TROPONIN T ROCHE = NEGATIVE RESULTS HETEROPHILE ANTIBODY TEST PERFORMED = NEGATIVE NEW SAMPLE RESULT = 88.9 NG/L ADDITIONAL LAB RESULT PROVIDED: RHEUMATOID FACTOR RESULT = NEGATIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR A 43 YEAR OLD MALE PATIENT. THE CUSTOMER MENTIONED THE PATIENT IS A COMPETITIVE BASKETBALL PLAYER AND HAD AN EPISODE OF EXTRASYSTOLE A FEW MONTHS AGO AND IS TAKING 2.5 MG/DAY OF BETAPROLOL (BETA-BLOCKER). THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED EXPECTED VALUES FOR MALE PATIENTS: POSITIVE >/= 34.2 NG/L) (B)(6) 2025 SID (B)(6) RESULTS = 106.1 NG/L, 111.9 NG/L, SAMPLE TESTED WITH TROPONIN I BECKMAN AND TROPONIN T ROCHE = NEGATIVE RESULTS HETEROPHILE ANTIBODY TEST PERFORMED = NEGATIVE NEW SAMPLE RESULT = 88.9 NG/L .ADDITIONAL LAB RESULT PROVIDED: RHEUMATOID FACTOR RESULT = NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2629244 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 77552UD00 00380740118099

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male ARC I2000SR INST, 03M74-02, ISR51549