BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1213120 · Received October 23, 2008

    Report

    Report Number
    1823260-2008-07858
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER STATED A DOCTOR HAD QUESTIONED SOME SODIUM RESULTS. THE USER PULLED SAMPLES, RECALIBRATED THE ISE AND REPEATED THE SAMPLES. USER STATED THE REPEAT RESULTS WERE DIFFERENT FROM THE INITIAL RESULTS. FIVE PATIENT SAMPLES WERE INVOLVED. ONE EXAMPLE WAS PROVIDED. INITIAL RESULT 126 MOL/L, REPEAT ON ANOTHER ANALYZER GAVE 128 MMOL/L, REPEAT ON THIS ANALYZER GAVE 132 MOL/L. ERRONEOUS RESULT WAS REPEATED. USER WAS UNCERTAIN OF PT MEDICAL HISTORY, DIAGNOSIS, MEDICATIONS, OR TREATMENT AND COULD NOT PROVIDE THIS INFORMATION. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE EVAPORATED INTERNAL STANDARD. A FIELD CORRECTION FOR THIS ISSUE HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK