BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1172268 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07026
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING ERRONEOUS RESULTS FOR FT4 FOR ONE PATIENT WHO HAD FOUR SAMPLES DRAWN ON DIFFERENT DAYS. SAMPLE 1 DRAWN IN 2008, INITIAL RESULT 7.77 NG/DL, REPEAT ON SAME ANALYZER 7.77 NG/DL. REPEAT ON ANOTHER ANALYZER GAVE 1.30 NG/DL. SAMPLE 2 DRAWN THE NEXT DAY, INITIAL RESULT 7.77 NG/DL, REPEAT ON SAME ANALYZER 7.77 NG/DL. REPEAT ON ANOTHER ANALYZER GAVE 1.91 NG/DL. SAMPLE 3 DRAWN THE FOLLOWING DAY, INITIAL RESULT 7.77 NG/DL, REPEAT ON SAME ANALYZER 7.77 NG/DL. REPEAT ON ANOTHER ANALYZER GAVE 1.13 NG/DL. SAMPLE 4 DRAWN TWO DAYS LATER, INITIAL RESULT 7.77 NG/DL, REPEAT ON SAME ANALYZER 7.77 NG/DL. REPEAT ON ANOTHER ANALYZER GAVE 4.88 NG/DL. INITIAL RESULTS WERE REPORTED. NO INFORMATION WAS PROVIDED TO DETERMINE IF PATIENT WAS ADVERSELY AFFECTED. THE FIELD SERVICE REP DETERMINED THE ISSUE WAS WITH THE PATIENT SAMPLE AND CHECKED THE ANALYZER. PERFORMANCE TESTS WERE PERFORMED. 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 29 YR