BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 21403970 · Received February 18, 2025

    Report

    Report Number
    3005094123-2025-00077
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    February 1, 2025
    Report Date
    April 3, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740096366
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 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. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT HIGH SENSITIVE TROPONIN-I ASSAY (LIST 3P25) DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIST NUMBER AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. PER PRODUCT LABELING, 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. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT UNKNOWN, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE LITERATURE ARTICLE (LETTER TO THE EDITOR) BY KAVSAK, PETER A., ET.AL., ¿IMPORTANT QUALITY PARAMETERS FOR MACROCOMPLEX INVESTIGATION FOR CARDIAC TROPONIN¿, CLINICAL BIOCHEMISTRY 135 ELSEVIER INC. (JAN 1, 2025), MENTIONED ONE PATIENT (PATIENT 1) GENERATED A FALSE POSITIVE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT COMPARED TO A NORMAL RESULT OBTAINED WHEN USING THE ORTHO HIGH SENSITIVE TROPONIN-I ASSAY ON THE VITROS XT 7600 ANALYZER. PATIENT 1 HAD AN INITIAL RESULT OF 46 NG/L USING THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY. WHEN THE PATIENT SAMPLE WAS TESTED WITH THE ORTHO STAT HIGH SENSITIVE TROPONIN-I ASSAY IT YIELDED A RESULT OF < 1 NG/L. POLYETHYLENE GLYCOL (PEG) PRECIPITATION ON PAIRED EDTA AND LITHIUM HEPARIN PLASMA SAMPLES FROM PATIENT 1 YIELDED 0 % RECOVERY WITH BOTH THE OLD AND NEW PEG SOLUTIONS (NOTE: OUR ARCHITECT ANALYZER¿S LOWER ANALYTICAL LIMIT FOR HS-CTNI IS 0.0000 NG/L, HOWEVER THE LOWEST PATIENT REPORTED RESULT IS < 1 NG/L, WHICH IS CONGRUENT WITH THE REPORTED LIMIT OF DETECTION FOR THIS ASSAY IN WHOLE NUMBERS). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE LITERATURE ARTICLE (LETTER TO THE EDITOR) BY KAVSAK, PETER A., ET.AL., ¿IMPORTANT QUALITY PARAMETERS FOR MACROCOMPLEX INVESTIGATION FOR CARDIAC TROPONIN¿, CLINICAL BIOCHEMISTRY 135 ELSEVIER INC. (JAN 1, 2025), MENTIONED ONE PATIENT (PATIENT 1) GENERATED A FALSE POSITIVE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT COMPARED TO A NORMAL RESULT OBTAINED WHEN USING THE ORTHO HIGH SENSITIVE TROPONIN-I ASSAY ON THE VITROS XT 7600 ANALYZER. PATIENT 1 HAD AN INITIAL RESULT OF 46 NG/L USING THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY. WHEN THE PATIENT SAMPLE WAS TESTED WITH THE ORTHO STAT HIGH SENSITIVE TROPONIN-I ASSAY IT YIELDED A RESULT OF < 1 NG/L. POLYETHYLENE GLYCOL (PEG) PRECIPITATION ON PAIRED EDTA AND LITHIUM HEPARIN PLASMA SAMPLES FROM PATIENT 1 YIELDED 0 % RECOVERY WITH BOTH THE OLD AND NEW PEG SOLUTIONS (NOTE: OUR ARCHITECT ANALYZER¿S LOWER ANALYTICAL LIMIT FOR HS-CTNI IS 0.0000 NG/L, HOWEVER THE LOWEST PATIENT REPORTED RESULT IS < 1 NG/L, WHICH IS CONGRUENT WITH THE REPORTED LIMIT OF DETECTION FOR THIS ASSAY IN WHOLE NUMBERS). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60088 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740096366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2K PROC MOD, 03M74-01, 116UNKNOWND13| ARC I2K PROC MOD, 03M74-01, 116UNKNOWND13