BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 868653 · Received June 19, 2007

    Report

    Report Number
    1415939-2007-00172
    Event Type
    Other
    Date Received
    June 19, 2007
    Date of Event
    June 12, 2007
    Report Date
    June 13, 2007
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES, THAT ONE PT SAMPLE GENERATED AN INITIAL ARCHITECT STAT TROPONIN-I ASSAY RESULT OF 1.20 UG/L. SIX HRS LATER, ANOTHER SAMPLE WAS DRAWN AND GENERATED A STAT TROPONIN-I ASSAY RESULT OF LESS THAN 0.01 UG/L. THE FOLLOWING DAY, ANOTHER SAMPLE WAS DRAWN AND GENERATED A STAT TROPONIN-I ASSAY RESULT OF 0.02 UG/L. THE CUSTOMER THEN REPEATED THE SAMPLES THAT GENERATED INITIAL RESULTS OF 1.20 UG/L AND LESS THAN 0.01 UG/L AND RECEIVED RESULTS OF 0.02 UG/L AND 0.00 UG/L RESPECTIVELY. CONTROLS HAVE BEEN WITHIN SPECIFICATIONS ON ALL RUNS. THE PT UNDERWENT A SURGICAL PROCEDURE BASED ON THE INITIAL ELEVATED RESULT OF 1.20 UG/L. THERE IS NO FURTHER PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I CMIA FOR MEASUREMENT OF CARDIAC TROPONIN-I MMI ABBOTT LABORATORIES NA 13037UN06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other ARCHITECT I2000SR ANALYZER LIST# 3M74-01