BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 2061422 · Received April 18, 2011

    Report

    Report Number
    1823260-2011-02096
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE RECEIVING QUESTIONABLY HIGH RESULTS FOR ION SELECTIVE ELECTRODE (ISE) SODIUM AND POTASSIUM THAT WERE REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN ASKED FOR A RETEST AND DID NOT ACT ON THE RESULTS. THE REPEAT RESULTS CAME BACK NORMAL. THE RETESTING WAS PERFORMED ON THE SAME C501 AND A DIFFERENT C501. THE INITIAL SODIUM RESULT WAS 163 MMOL/L. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 136 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 137 MMOL/L. THE INITIAL POTASSIUM RESULT WAS 4.24 MMOL/L. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 3.58 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 3.54 MMOL/L. THERE WAS NO ADVERSE AFFECT TO THE PATIENT BECAUSE OF THIS EVENT. THERE WERE NO LOT NUMBERS PROVIDED FOR THE SODIUM OR POTASSIUM ELECTRODES. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CELL RINSE MECHANISM WASH CUVETTE WAS VERY SLIGHTLY OUT OF SPECIFICATION. HE ADJUSTED THE CELL RINSE CUVETTE LEVEL TO 5 MM FROM THE TOP OF CUVETTE. HE ALSO CHECKED AND CLEANED THE ISE WASTE IN THE BACK OF THE ANALYZER. PERFORMANCE TESTING WAS DONE WITH PASSING RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1