BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 TROPONIN I

    MDR report key: 1772230 · Received July 22, 2010

    Report

    Report Number
    2017183-2010-00031
    Event Type
    Other
    Date Received
    July 22, 2010
    Date of Event
    June 20, 2010
    Report Date
    June 22, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JHX
    PMA / PMN Number
    K034055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SYSTEM DATA INDICATE THAT THERE ARE NO KNOWN SYSTEM CAUSES WHICH MAY HAVE CONTRIBUTED TO THE INITIAL DISCORDANT POSITIVE IMMULITE 2500 TROPONIN TEST RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISCORDANT FALSE POSITIVE IMMULITE 2000 TROPONIN ASSAY RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE CUSTOMER PERFORMED REPEAT TESTING AND THE RESULTS WERE NEGATIVE. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSE POSITIVE STAT TROPONIN ASSAY TEST RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 TROPONIN I TROPONIN IMMUNOASSAY JHX SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 251

    Patients

    Seq Age Sex Outcome Treatment
    1