BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1902110 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06808
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    AFTER RECEIVING QUESTIONABLE ISE RESULTS, THE USER REPLACED THE ISE ELECTRODES, PERFORMED CALIBRATION, QUALITY CONTROL AND REPEATED TESTING OF THE PATIENT SAMPLES ON COBAS C501 ANALYZER (B)(4). THE USER PROVIDED DATA FOR THREE PATIENT SAMPLES WHICH WERE DISCREPANT. ALL RESULTS ARE IN MMOL/L. PATIENT SAMPLE 1 INITIAL SODIUM RESULT WAS 134 AND THE REPEAT RESULT WAS 150. PATIENT SAMPLE 2 INITIAL SODIUM RESULT WAS 131 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 3 INITIAL SODIUM RESULT WAS 131 AND THE REPEAT RESULT WAS 139. THE USER STATED THE RESULTS WERE ACCOMPANIED BY DATA FLAGS, BUT NO INFORMATION WAS PROVIDED TO DETERMINE WHICH RESULTS WERE FLAGGED. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE USER BELIEVED THE PHYSICIANS DID NOT ACT ON THE RESULTS. HE DID RECEIVE CALLS FROM A COUPLE QUESTIONING THE RESULTS. THE USER DOES NOT BELIEVE THE PATIENTS WERE ADVERSELY AFFECTED. THE LOT NUMBER OF THE SODIUM ELECTRODE WAS NOT PROVIDED. THE USER STATED THEY WERE NOT USING FRESH CALIBRATION MATERIAL FOR EACH CALIBRATION. THEY WOULD USE THE CALIBRATION MATERIAL ON ONE ANALYZER THEN THE SAME SET WOULD BE USED ABOUT AN HOUR LATER ON THE OTHER INSTRUMENT. PRODUCT LABELING STATES "OPENED AMPULES SHOULD BE USED IMMEDIATELY. REMAINING CONTENT MUST NOT BE STORED TO AVOID INACCURATE CALIBRATIONS." THE FIELD SERVICE REPRESENTATIVE FOUND A MISALIGNED ISE PROBE AND ALIGNED IT. HE PERFORMED MECHANICAL CHECKS OF THE INSTRUMENT AND PERFORMED ISE CHECKS WITHOUT ERRORS. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED ISE PRECISION TESTING.

    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