BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I REAGENT KIT

    MDR report key: 20194024 · Received September 11, 2024

    Report

    Report Number
    1415939-2024-00054
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 14, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    UDI-DI
    00380740048525
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT STAT TROPONIN-I REAGENT KIT, LIST NUMBER 02K41-27, ABBOTT PARK, IL, USA IN SECTION D OF THIS REPORT TO ARCHITECT I1000SR, LIST NUMBER 01L86-40, IRVING, TX, USA. MDR NUMBER 3016438761-2024-00603-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    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 A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE IS 0-29 NG/ML): PATIENT 1 INITIAL RESULT WAS 141.6, REPEAT RESULT WAS <7, REPEAT RESULT, ON ANOTHER ANALYZER, WAS <7 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE IS 0-29 NG/ML): PATIENT 1 INITIAL RESULT WAS 141.6, REPEAT RESULT WAS <7, REPEAT RESULT, ON ANOTHER ANALYZER, WAS <7 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557096 ARCHITECT STAT TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT LABORATORIES 07500UN24 00380740048525

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I1000SR INTGR, 01L86-40, (B)(6).| ARC I1000SR INTGR, 01L86-40, (B)(6).