BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1231110 · Received November 11, 2008

    Report

    Report Number
    1823260-2008-08362
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 12, 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 FREE T4 RESULTS. INITIAL RESULT GAVE 26.3 PMOL/L. SAMPLE REPEATED TWICE GIVING 24.2 PMOL/L USING A NEW FREE T4 REAGENT LOT NUMBER AND 19 PMOL/L BY ANOTHER ANALYZER. NO INFO WAS PROVIDED TO DETERMINE IF PT WAS ADVERSELY AFFECTED. IF ADD'L 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 E MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR