BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1890020 · Received November 3, 2010

    Report

    Report Number
    1823260-2010-06550
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED ERRONEOUS ISE RESULTS FOR THREE PATIENT SAMPLES. ALL TESTING WAS PERFORMED ON THIS COBAS 6000 C501 ANALYZER. PATIENT 1, INITIAL SODIUM RESULT WAS 124 MMOL/L (ACCOMPANIED BY A DATA FLAG). THE REPEAT SODIUM RESULT GAVE 134 MMOL/L (ACCOMPANIED BY A DATA FLAG). THE INITIAL POTASSIUM RESULT WAS 4.18 MMOL/L. THE REPEAT POTASSIUM RESULT WAS 4.59 MMOL/L. PATIENT 2, FEMALE, INITIAL SODIUM RESULT WAS 126 MMOL/L (ACCOMPANIED BY A DATA FLAG). THE REPEAT SODIUM RESULT WAS 144 MMOL/L. PATIENT 3, FEMALE, INITIAL SODIUM RESULT WAS 130 MMOL/L (ACCOMPANIED BY A DATA FLAG). THE REPEAT SODIUM RESULT WAS 137 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT AFFECTED BY THE ERRONEOUS RESULTS. THE SODIUM AND POTASSIUM ELECTRODE LOT NUMBERS WERE NOT PROVIDED. THE REFERENCE ELECTRODE LOT NUMBER WAS 62801401. THE FIELD SERVICE REPRESENTATIVE DETERMINED A BAD SIPPER PROBE AND TUBING WAS THE CAUSE OF THE DISCREPANCIES. HE REPLACED THE SIPPER PROBE AND TUBING AND THE ISE PINCH VALVE TUBING. THE FIELD SERVICE REPRESENTATIVE RAN PERFORMANCE TESTS WHICH WERE ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1