BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1012733 · Received March 12, 2008

    Report

    Report Number
    1823260-2008-02371
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT FERRITIN RESULTS. INITIAL RESULT 0.5 NG/ML, REPEATED TWICE GIVING 48 NG/ML AND 47 NG/ML. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS C601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK