BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1231136 · Received November 12, 2008

    Report

    Report Number
    1823260-2008-08355
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    November 27, 2007
    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

    USER EXPERIENCED DISCREPANT TSH RESULTS FOR FOUR SAMPLES FROM ONE PT ON TWO SEPARATE DATES. SAMPLE 1 INITIAL RESULT 0.44 UIU/ML. SAME SAMPLE REPEATED THREE TIMES BY DIFFERENT METHODOLOGIES GAVE 2.38, 2.7 AND 0.78 MIU/ML. SAMPLE 2 INITIAL RESULT 2.9 UIU/ML. SAME SAMPLE REPEATED THREE TIMES BY DIFFERENT METHODOLOGIES GAVE 15.5, 16.6 AND 5.42 UIU/ML. SAMPLE 3, 2008, INITIAL RESULT 0.13 UIU/ML. SAME SAMPLE REPEATED THREE TIMES BY DIFFERENT METHODOLOGIES GAVE 0.78, 0.81 AND 0.78 UIU/ML. SAMPLE 4, 2008, INITIAL RESULT 1.1 UIU/ML. SAME SAMPLE REPEATED THREE TIMES BY DIFFERENT METHODOLOGIES GAVE 5.42, 5.7 AND 5.42 UIU/ML. NO INFO WAS PROVIDED TO DETERMINE IF ANY ADVERSE EVENTS WERE REPORTED. 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 UNK