BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1193392 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07433
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT THYROID TESTING RESULTS FOR ONE PATIENT SAMPLE. INITIAL RESULTS: TSH 0.44 MIU/ML, T4 14.2 UG/DL, T3 172 NG/DL. REPEAT TESTING ON ANOTHER ANALYZER: TSH 1.7 MIU/ML, T4 5.3 UG/DL, T3 107 NG/DL. INITIAL RESULTS WERE REPORTED. NO INFORMATION WAS PROVIDED TO DETERMINE IF ANY ADVERSE EVENTS OCCURRED. 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 VICODIN| FLUOXETINE| PRAZOSIN| DOCUSATE| ALBUTEROL INHALER| ESOMEPRAZOLE| OXAPROZIN| QUETIAPINE| DIAZEPAM| ACETAMINOPHEN| MELOXICAM| IBUPROFEN| LAMOTRIGINE| NICOTINE TRANSDERMAL PATCH