BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1162209 · Received September 16, 2008

    Report

    Report Number
    1823260-2008-06925
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING TSH RESULTS THAT DO NOT MEET CLINICAL PICTURE. INITIAL RESULT 48 MIU/ML, REPEAT 45 MIU/ML. REPEATED ON ANOTHER ANALYZER, 9.0 MIU/ML. PRIOR SAMPLE TESTED IN 2008 WAS NEARLY 50 MIU/ML. NO INFORMATION WAS PROVIDED TO DETERMINE IF INITIAL RESULT WAS REPORTED. IF ADDITIONAL INFORMATION 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