BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1001794 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01673
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH A FREE T4 RESULT WHICH DID NOT FIT CLINICAL PICTURE. INITIAL RESULT GAVE 0.122 NG/DL. A SECOND SAMPLE WAS OBTAINED IN 2008 GIVING 2.53 NG/DL. THE INITIAL SAMPLE WAS REPEATED GIVING 2.16 NG/DL. ERRONEOUS RESULT WAS REPORTED. PATIENT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    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 24 YR