BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1022708 · Received March 25, 2008

    Report

    Report Number
    1823260-2008-02845
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PT SAMPLES WITH DISCREPANT RESULTS FOR CREATININE. PT 1, INITIAL RESULT GAVE 130 MG/L; REPEAT GAVE 1.33 MG/L. PT 2, INITIAL RESULT GAVE 94 MG/L; REPEAT GAVE 8.7 MG/L. NO INFO PROVIDED 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 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK