BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1232548 · Received November 13, 2008

    Report

    Report Number
    1823260-2008-08369
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    September 12, 2008
    Report Date
    November 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBC
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED TWO SAMPLES FOR ONE PATIENT FOR PROBNP WHICH DID NOT FIT THE CLINICAL PICTURE. SAMPLE 1, RESULT OF 3610 NG/L. SAMPLE 1 WAS NOT REPORTED. SAMPLE 2, TESTED 2008, RESULT WAS 1733 NG/L. SAMPLE 2 WAS NOT REPEATED. THE PATIENT WAS RECEIVING DIGITOXIN. NO INFORMATION WAS PROVIDED TO DETERMINE IF ANY ADVERSE EVENTS WERE REPORTED. 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 NBC ROCHE DIAGNOSTICS E MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR DIGITOXIN