BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 20223327 · Received September 16, 2024

    Report

    Report Number
    3005094123-2024-00473
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 31, 2024
    Report Date
    October 2, 2024
    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

    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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELLING, AND DEVICE HISTORY RECORDS. RETURNS WERE NOT AVAILABLE. THE REVIEW OF HISTORICAL PERFORMANCE OF REAGENT LOT 63197UD01, WAS COMPLETED. TRENDING REVIEW DETERMINED NO TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON LOT 63197UD01 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. ACCURACY OF THE ASSAY HAS BEEN EVALUATED WITH A RETAINED IN-HOUSE KIT OF THE SAME LOT# 63197UD01 AND MET ALL SPECIFICATIONS, CONFIRMING THAT THIS LOT IS MEETING THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I PRODUCT REQUIREMENTS. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. ADDITIONALLY, ABBOTT HAS NOT ESTABLISHED EXPECTED RANGES FOR PATIENTS < 21 YEARS OLD. BASED ON THE INVESTIGATION, THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I LOT NUMBER 63197UD01 IS PERFORMING AS EXPECTED AND NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT TROPONIN-I RESULT ON A 17-YR OLD MALE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. RESULTS PROVIDED: INITIAL = 2.00 / 0.001 / 0.006 UG/L (REFERENCE RANGE: < 0.0342 UG/L); CK-MB IS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT ON A 17-YR OLD MALE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. RESULTS PROVIDED: INITIAL = 2.00 / 0.001 / 0.006 UG/L (REFERENCE RANGE: < 0.0342 UG/L); CK-MB IS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112526 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 63197UD01 00380740165093

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male ARC I2000SR INST, 03M74-02, (B)(6) | ARC I2000SR INST, 03M74-02, (B)(6)