BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1051574 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04142
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 26, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO PT SAMPLES WITH FREE T4 RESULTS THAT DO NOT FIT WITH CLINICAL PICTURE. PT 1: INITIAL FREE T4 GAVE 24.7 PMOL/L; REPEAT BY DIFFERENT METHODOLOGY GAVE 21.9 PMOL/L. TSH GAVE 1.66 MLU/L, NO REPEAT DATE PROVIDED. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IF ADD'L INFO IS REC'D, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 2

    TWO PT SAMPLES WITH FREE T4 RESULTS THAT DO NOT FIT WITH CLINICAL PICTURE. PT 2 INITIAL FREE T4 GAVE 26.8 PMOL/L; REPEAT BY DIFFERENT METHODOLOGY GAVE 22.8 PMOL/L. TSH GAVE 1.00 MLU/L; NO REPEAT DATA PROVIDED. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IF ADD'L INFO IS REC'D, 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
    2