BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1200101 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07628
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED A FALSELY HIGH VALVE FOR TROPONIN T. INITIAL RESULT 0.079 NG/ML. THE CLINICIAN CONTACTED THE LABORATORY AND STATED THE RESULT WAS NOT IN CONCORDANCE WITH THE CLINICAL SETTING OF THE PT. THE SAMPLE WAS RETESTED AND GAVE A RESULT OF <0.010 NG/ML. NO INFO WAS PROVIDED TO DETERMINE IF PT WAS ADVERSELY AFFECTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK