BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 23882716 · Received December 23, 2025

    Report

    Report Number
    3005094123-2025-00662
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 21, 2025
    Report Date
    March 11, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740118099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3P25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98, WITH 510K/PMA/BLA NUMBER K191595.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE 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 IN HOUSE TESTING. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 79395UD00, HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR LIST NUMBER 03P25. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES WITH THE LOT NUMBER AND COMPLAINT ISSUE. ACCURACY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. 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. 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. ADDITIONALLY, THE TICKET DOCUMENTS THAT THE SAMPLE WAS HEMOLYZED. AS PER PRODUCT LABELING, FOR ACCURATE RESULTS, SERUM AND PLASMA SPECIMENS SHOULD BE FREE OF FIBRIN, RED BLOOD CELLS, AND OTHER PARTICULATE MATTER, INCLUDING CRYOPRECIPITATE. IF THE SPECIMENS CONTAIN FIBRIN, RED BLOOD CELLS, OR OTHER PARTICULATE MATTER, INCLUDING CRYOPRECIPITATE, OR HAVE BEEN STORED AT 2-8°C FOR MORE THAN 24 HOURS, CENTRIFUGE AT A RELATIVE CENTRIFUGAL FORCE (RCF) OF 3,000 TO 3,500 X G FOR 30 MINUTES BEFORE TESTING TO ENSURE CONSISTENCY IN RESULTS. BASED ON THE INVESTIGATION, THE DEVICE MET PERFORMANCE SPECIFICATION AND PERFORMED AS INTENDED AT THE CUSTOMER SITE, THEREFORE THERE IS NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 79395UD00. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT FOR A 16-YEAR-OLD MALE PATIENT GENERATED ON THE ARCHITECT I2000SR ANALYZER. THE SAMPLE APPEARED HEMOLYZED (HEMOLYSIS: 72 (+)). THE FOLLOWING DATA WAS PROVIDED: ON 21DEC2025, SID (B)(6). 1ST RESULT: 101 PG/ML ((B)(6) ). 2ND RESULT: < 4 PG/ML ((B)(6) ). 3RD RESULT: < 4 PG/ML ((B)(6) ). NO CUSTOMER CUTOFF WAS PROVIDED, THEREFORE USING THE PACKAGE INSERT MALE CUTOFF OF 34.2 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT FOR A 16-YEAR-OLD MALE PATIENT GENERATED ON THE ARCHITECT I2000SR ANALYZER. THE SAMPLE APPEARED HEMOLYZED (HEMOLYSIS: 72 (+). THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6). 1ST RESULT: 101 PG/ML (B)(6), 2ND RESULT: < 4 PG/ML (B)(6), 3RD RESULT: < 4 PG/ML (B)(6). NO CUSTOMER CUTOFF WAS PROVIDED, THEREFORE USING THE PACKAGE INSERT MALE CUTOFF OF 34.2 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398293 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 79395UD00 00380740118099

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)