BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 9602342 · Received January 17, 2020

    Report

    Report Number
    3005094123-2020-00019
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    December 27, 2019
    Report Date
    February 27, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT STAT HIGH SENSITIVE TROPONIN-I, LIST NUMBER 03P25-27, AND A.I.D.D LONGFORD, LISNAMUCK CO. LONGFORD, LONGFORD NA, IRL MANUFACTURING SITE IN SECTION D OF THIS REPORT TO ARCHITECT I2000SR ANALYZER; LN 03M74-02; SERIAL # (B)(4), AND ABBOTT MANUFACTURING INC, 1921 HURD DRIVE, IRVING, TEXAS, USA, 75038, MANUFACTURING SITE OF NEW SUSPECT DEVICE. MDR NUMBER 1628664-2020-00083 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER = (B)(6) AND (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3P25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TROPONIN RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 (B)(6) INITIAL = 119.87NG/ L / SECOND SAMPLE 3 HOURS LATER (B)(6)= <5NG/L / FIRST SAMPLE RETEST = <5NGL. THE (B)(6) MALE HAD AN EKG PERFORMED, ADDITIONAL BLOOD DRAWS, AND WAS IN THE HOSPITAL FOR 3 HOURS. THERE WAS NO REPORTED ADVERSE IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64530 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I TROPONIN-I MMI ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD 09359UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR ARCHITECT I2000SR ANALYZER, LN 03M74-02,| ARCHITECT I2000SR ANALYZER, LN 03M74-02,| SERIAL # (B)(4)| SERIAL #(B)(4)