BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1200095 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07616
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT CORTISOL RESULTS FOR ONE PATIENT. INITIAL RESULT 4.60 UG/DL, REPEAT 2008 GAVE 503.7 UG/DL. DOCTOR QUESTIONED THE INITIAL RESULT. HE INFORMED THE USER HE NEEDED ACCURATE INFORMATION TO CORRECTLY DIAGNOSE THE LOCATION OF A MALIGNANT TUMOR AND WAS UNABLE TO MAKE THE DIAGNOSIS AT THE TIME OF THE INITIAL RESULT. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE PATIENT'S STATUS AT THIS TIME. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE CAUSE OF THE DISCREPANT RESULTS. HE VERIFIED ANALYZER OPERATION BY RUNNING PATIENT SAMPLES.

    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