BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 20279059 · Received September 23, 2024

    Report

    Report Number
    3005094123-2024-00490
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    September 11, 2024
    Report Date
    November 27, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740165086
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES, OR DEVIATIONS WITH THE COMPLAINT LOT. TICKET SEARCH BY LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE COMPLAINT LOT. TICKET TRENDING REVIEW HAS NOT IDENTIFIED ANY RELATED TRENDS IN WHICH THERE WAS A PRODUCT ISSUE. THE OVERALL PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I REAGENT WAS REVIEWED USING FIELD DATA FROM CUSTOMERS. A REVIEW OF FIELD DATA FOR THE OVERALL PERFORMANCE OF LOT 64189UD01 INDICATED THE PATIENT MEDIAN RESULTS ARE WITHIN THE ESTABLISHED LIMITS. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I, REAGENT LOT 64189UD01.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 HEART STENT PATIENT RETESTED 6 MONTHS AFTER PROCEDURE RESULT = 0.116 NG/ML BECKMAN RESULT IS NEGATIVE, ELECTROCARDIOGRAM AND IMAGING TESTS NORMAL. PATIENT 2 INITIAL TEST = 0.042 NG/ML REPEAT TEST = 0.044 NG/ML BECKMAN RESULT IS NEGATIVE. REFERENCE RANGE: 0-0.026 NG/ML 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 TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 HEART STENT PATIENT RETESTED 6 MONTHS AFTER PROCEDURE RESULT = 0.116 NG/ML BECKMAN RESULT IS NEGATIVE, ELECTROCARDIOGRAM AND IMAGING TESTS NORMAL. PATIENT 2 INITIAL TEST = 0.042 NG/ML REPEAT TEST = 0.044 NG/ML BECKMAN RESULT IS NEGATIVE. REFERENCE RANGE: 0-0.026 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502344 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 64189UD01 00380740165086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I1000SR MOD, 01L86-01, (B)(6)| ARC I1000SR MOD, 01L86-01, (B)(6)