BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL MODULE

    MDR report key: 1102018 · Received August 7, 2008

    Report

    Report Number
    1823260-2008-06019
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 18, 2008
    Report Date
    August 7, 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

    ONE PT SAMPLE WITH DISCREPANT TSH RESULTS. INITIAL RESULT 80 UIU/ML. SECOND SAMPLE FROM SAME PT GAVE INITIAL RESULT OF <0.1; REPEAT GAVE <0.002 UUI/ML USING DIFFERENT METHODOLOGIES. THE SECOND SAMPLE WAS REPEATED BY INITIAL METHOD GAVE 81.2 UIU/ML AND WITH DILUTION GAVE 150.2 UIU/ML. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR