BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1230571 · Received November 13, 2008

    Report

    Report Number
    1823260-2008-08366
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED LOW SODIUM AND POTASSIUM RESULTS FOR ONE PT SAMPLE. INITIAL SODIUM RESULT WAS 123 MMOL/L, REPEAT RESULT 142 MMOL/L. INITIAL POTASSIUM RESULT WAS 2.8 MMOL/L, REPEAT RESULT WAS 3.4 MMOL/L. INITIAL RESULTS WERE REPORTED. THE ISE RESULTS WERE ACTED UPON AND PT WAS TREATED WITH SODIUM AND POTASSIUM. USER COULD NOT PROVIDE ANY CURRENT INFO ABOUT THE PT. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE BUT NOTED THERE WAS A POSSIBLE CLOT IN ISE SYSTEM. HE STATED USER HAD NOTICED DROPS OF LIQUID ON ISE ELECTRODES AND CLEANED THEM AND ALSO REMOVED AND RESEATED THE ISE ELECTRODES. USER ALSO PERFORMED CALIBRATION WHICH IMPROVED THE PERFORMANCE OF THE ASSAY. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Other