BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1052947 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04330
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    February 18, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO EXTERNAL PROFICIENCY SURVEY SAMPLES WITH DISCREPANT GENTAMICIN RESULTS. SAMPLE 1, 2008, RESULT REPORTED 9.9 UG/ML, TARGET VALUE 14.42 UG/ML. SAMPLE 2, 2008, RESULT REPORTED 3.0 UG/ML, TARGET VALUE 3.74 UG/ML. NO PT SAMPLES WERE INVOLVED. 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 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM JJE ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK