BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1325983 · Received January 15, 2009

    Report

    Report Number
    1823260-2009-00351
    Event Type
    Malfunction
    Date Received
    January 15, 2009
    Date of Event
    December 5, 2008
    Report Date
    January 15, 2009
    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

    USER REPORTS ONE PT SAMPLE WITH DISCREPANT FREE T4 RESULTS. INITIAL RESULT GAVE 26.2; REPEAT ON SAME ANALYZER GAVE 28.1. REPEAT ON ANOTHER ANALYZER GAVE 21.8. (NO UNITS OF MEASURE PROVIDED.) NO INFO PROVIDED TO DETERMINE IF PT WAS ADVERSELY AFFECTED. IF ADDITIONAL 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 CORP. E MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR