BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS E MODULE

    MDR report key: 850893 · Received May 15, 2007

    Report

    Report Number
    1823260-2007-04138
    Event Type
    Malfunction
    Date Received
    May 15, 2007
    Date of Event
    April 29, 2007
    Report Date
    May 15, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    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

    ALLEGATION OF 6 PT SAMPLES WITH ELEVATED FREE T4 RESULTS THAT DO NOT FIT CLINICAL PICTURE. INITIAL RESULTS WERE ELEVATED AS COMPARED TO USING THE SAME METHOD POST HBT AND USING DIFFERENT METHOD. FIVE EXAMPLES WERE PROVIDED: PT 1 INITIAL 26 PMOL/L, POST HBT 14.1 PMOL/L, DIFFERENT METHOD 15.7 PMOL/L; PT 2 INITIAL 43.7 PMOL/L, POST HBT 31.5PMOL/L, DIFFERENT METHOD 32.8 PMOL/L; PT 3 INITIAL 43.9 PMOL/L, POST HBT 32.1PMOL/L, DIFFERENT METHOD 29.5 PMOL/L. PT 4 INITIAL 34.5 PMOL/L, POST HBT 24.3 PMOL/L, DIFFERENT METHOD 26.1 PMOL/L. PT 5 INITIAL 49.4 PMOL/L, POST HBT 33.8 PMOL/L, DIFFERENT METHOD 44.0 PMOL/L. THE INVESTIGATIONAL UNIT WAS ABLE TO CONFIRM THE ELEVATED FT4 VALUES FOR PTS 1 THROUGH 4. INTERFERENCE FACTORS WERE IDENTIFIED FOR PT SAMPLES 1 THROUGH 4. THE SAMPLE FROM PT 5 WAS UNABLE TO BE INVESTIGATED DUE TO STORAGE AND TRANSPORTATION ISSUES. IF ADD'L INFO IS RECEIVED , APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS E MODULE IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS CORP. E170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR