BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 23135263 · Received September 24, 2025

    Report

    Report Number
    3005094123-2025-00473
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 17, 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

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03P25-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98, WITH 510K NUMBER K191595. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION 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. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 75076UD01. HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR LIST NUMBER 03P25. A REVIEW OF STATISTICAL PROCESS CONTROL (SPC) CHARTS FOR THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I COMPLAINT LOT INDICATES THAT THE LOT IS PERFORMING WITHIN ESTABLISHED CONTROL LIMITS. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY USING WORLDWIDE DATA. 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. PER PRODUCT LABELING, 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. IN THIS CASE, PER THE EXPECTED VALUES SECTION IN THE PRODUCT LABELING, THE 99TH PERCENTILE CUTOFF FOR FEMALE PATIENTS IN THE AGE RANGE OF 21 TO 75 YEARS IS 15.6 PG/ML (15.6 NG/L). ABBOTT HAS NOT ESTABLISHED EXPECTED RANGES FOR FEMALE PATIENTS < 21 YEARS OLD. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 75076UD01 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I FOR A 11 DAY OLD FEMALE PATIENT WITH NO SYMPTOMS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE FEMALE = 15.6 PG/ML, MALE = 34.2 PG/ML): ON (B)(6) 2025, INITIAL TROPONIN RESULT= 971.2 PG/ML PLATFORM M RESULTS: HS TROPONIN T RESULT= 94.6 (REFERENCE RANGE 14.2-18.4), HS TROPONIN I RESULT= 378.6 (REFERENCE RANGE 16.6-43.5), TROPONIN C RESULT= 7.83 .(REFERENCE RANGE = 1) THE CUSTOMER PERFORMED A PEG PRECIPITATION THAT GENERATED A LOWER RESULT, WHICH THE CUSTOMER SUSPECTS THE PRESENCE OF MACROTROPONIN. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I FOR A 11 DAY OLD FEMALE PATIENT WITH NO SYMPTOMS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE FEMALE = 15.6 PG/ML, MALE = 34.2 PG/ML): ON (B)(6) 2025, INITIAL TROPONIN RESULT= 971.2 PG/ML PLATFORM M RESULTS: HS TROPONIN T RESULT= 94.6 (REFERENCE RANGE 14.2-18.4), HS TROPONIN I RESULT= 378.6 (REFERENCE RANGE 16.6-43.5), TROPONIN C RESULT= 7.83 (REFERENCE RANGE = 1) THE CUSTOMER PERFORMED A PEG PRECIPITATION THAT GENERATED A LOWER RESULT, WHICH THE CUSTOMER SUSPECTS THE PRESENCE OF MACROTROPONIN. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393795 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 75076UD01 00380740165093

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DA Female ARC I2000SR INST, 03M74-02, (B)(6)