BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 18346869 · Received December 18, 2023

    Report

    Report Number
    3005094123-2023-00377
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    December 5, 2023
    Report Date
    January 17, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELLING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. HISTORICAL PERFORMANCE OF REAGENT LOT 56447UD00 WAS EVALUATED USING WORLDWIDE DATA. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON LOT 56447UD00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. THE OVERALL PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE AND DETERMINED THAT PATIENT MEDIAN RESULT FOR THE LOT IS COMPARABLE WITH OTHER LOTS IN THE FIELD AND CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. PER THE PACKAGE INSERT, 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. 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. ANY CONDITION RESULTING IN MYOCARDIAL INJURY CAN POTENTIALLY INCREASE CARDIAC TROPONIN I LEVELS. 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. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I LOT NUMBER 56447UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS ON ONE MALE PATIENT, AGED 49. THE SAMPLE HAD BEEN TAKEN FROM HOME BY A NURSE. THE PATIENT WENT TO THE HOSPITAL AND WAS NEGATIVE BY ANOTHER METHOD(UNKNOWN). THE FOLLOWING INFORMATION WAS PROVIDED: INITIAL RESULT(SAMPLE TAKEN AT HOME) PROCESSED ON (B)(6) 2023 = 1790.4 NG/L; HOSPITAL RESULT = NEGATIVE(METHOD UNKNOWN); SAMPLE SENT TO MAYMAT LABORATORY AND TESTED ON TWO DIFFERENT ALINITYS = 1753.7 NG/L AND 1869.4 NG/L. HISTORICAL RESULTS: (B)(6) 2023 = 100 NG/L; (B)(6) 2022 = 95.7 NG/L; (B)(6) 2021 = 133.8 NG/L; (B)(6) 2021 = 101.5 NG/L; (B)(6) 2021 = 87 NG/L. INTERPRETATION OF RESULTS: MALE TROPONIN RESULT NEGATIVE: 34.2 NG/L 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 ON ONE MALE PATIENT, AGED 49. THE SAMPLE HAD BEEN TAKEN FROM HOME BY A NURSE. THE PATIENT WENT TO THE HOSPITAL AND WAS NEGATIVE BY ANOTHER METHOD(UNKNOWN). THE FOLLOWING INFORMATION WAS PROVIDED: INITIAL RESULT(SAMPLE TAKEN AT HOME) PROCESSED ON 05DEC2023 = 1790.4 NG/L HOSPITAL RESULT = NEGATIVE(METHOD UNKNOWN). SAMPLE SENT TO MAYMAT LABORATORY AND TESTED ON TWO DIFFERENT ALINITYS = 1753.7 NG/L AND 1869.4 NG/L. HISTORICAL RESULTS: (B)(6) 2023 = 100 NG/L. (B)(6) 2022 = 95.7 NG/L. (B)(6) 2021 = 133.8 NG/L. (B)(6) 2021 = 101.5 NG/L. (B)(6) 2021 = 87 NG/L. INTERPRETATION OF RESULTS: MALE TROPONIN RESULT NEGATIVE: 34.2 NG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78841 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 56447UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male ARC I1SR INTEG REFRB-SE, 01L87-97, (B)(6).| ARC I1SR INTEG REFRB-SE, 01L87-97, (B)(6).