BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 2223404 · Received August 25, 2011

    Report

    Report Number
    1823260-2011-04565
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 11, 2011
    Report Date
    October 27, 2011
    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

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE POSSIBLE ROOT CAUSE OF THE LOW SODIUM RESULTS IS MOST PROBABLY AN ERRONEOUS CALIBRATION DUE TO AN OVERLY CONCENTRATED ISE STANDARD HIGH. IN THE PACKAGE INSERT IT IS STATED THAT THE ISE STANDARD LOW AND HIGH ARE FOR SINGLE USE ONLY. ANOTHER POSSIBLE ROOT CAUSE COULD HAVE BEEN A LEAKAGE FLOW EITHER DUE TO AIR IN THE MEASURING CHANNEL OR LEAKAGE FLOW WHICH COMES FROM THE WASTE. NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ISE (ION SELECTIVE ELECTRODE) RESULTS FOR MULTIPLE PATIENT SAMPLES AND PROVIDED DATA FOR TEN PATIENT SAMPLES. THE INITIAL RESULTS WERE QUESTIONED AS THE CALIBRATIONS PERFORMED AFTERWARD WERE NOT ACCEPTABLE. ALL REPEAT TESTING WAS PERFORMED ON ANOTHER COBAS C501 ANALYZER AT THE SITE. ALL RESULTS ARE IN MMOL/L. PATIENT SAMPLE 1 INITIAL SODIUM RESULT WAS 126 AND THE REPEAT RESULT WAS 137. THE INITIAL POTASSIUM RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.2 (4.21). PATIENT SAMPLE 2 WAS FROM A (B)(6) MALE PATIENT. THE INITIAL SODIUM RESULT WAS 128 AND THE REPEAT RESULT WAS 142. THE INITIAL POTASSIUM RESULT WAS 3.6 AND THE REPEAT RESULT WAS 4.1 (4.05). PATIENT SAMPLE 3 WAS FROM A (B)(6) MALE PATIENT. THE INITIAL SODIUM RESULT WAS 127 AND THE REPEAT RESULT WAS 139. PATIENT SAMPLE 4 WAS FROM A (B)(6) FEMALE PATIENT. THE INITIAL SODIUM RESULT WAS 124 AND THE REPEAT RESULT WAS 131. THE INITIAL POTASSIUM RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.2 (4.16). PATIENT SAMPLE 5 WAS FROM A (B)(6) MALE PATIENT. THE INITIAL SODIUM RESULT WAS 127 AND THE REPEAT RESULT WAS 138. THE INITIAL POTASSIUM RESULT WAS 3.8 AND THE REPEAT RESULT WAS 4.31. PATIENT SAMPLE 6 WAS FROM A (B)(6) MALE PATIENT. THE INITIAL SODIUM RESULT WAS 128 AND THE REPEAT RESULT WAS 141. THE INITIAL POTASSIUM RESULT WAS 3.7 AND THE REPEAT RESULT WAS 4.2 (4.17). PATIENT SAMPLE 7 WAS FROM A (B)(6) FEMALE PATIENT. THE INITIAL SODIUM RESULT WAS 127 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 8 WAS FROM A (B)(6) FEMALE PATIENT. THE INITIAL SODIUM RESULT WAS 128 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 9 WAS FROM A (B)(6) MALE PATIENT. THE INITIAL SODIUM RESULT WAS 126 AND THE REPEAT RESULT WAS 138. THE INITIAL POTASSIUM RESULT WAS 3.6 AND THE REPEAT RESULT WAS 4.0 (4.03). PATIENT SAMPLE 10 WAS FROM A (B)(6) MALE PATIENT. THE INITIAL POTASSIUM RESULT WAS 4.5 AND THE REPEAT RESULT WAS 5.56. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE ISSUED. THE USER STATED NO PATIENTS WERE HARMED. NO PATIENTS WERE ADVERSELY AFFECTED. THE SODIUM AND POTASSIUM ELECTRODE LOT NUMBERS WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FLUIDIC FAILURE DUE TO THE ISE BATH NOT PROPERLY DISTRIBUTING ISE SOLUTION WHICH GENERATED ERRORS. HE CLEANED THE ISE BATH AND FLUSHED OUT THE SIPPER PROBE AS A PREVENTATIVE MEASURE. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION AND QUALITY CONTROL WITH ALL RESULTS IN PASSING RANGE. THE FIELD SERVICE REPRESENTATIVE RAN PERFORMANCE TESTING WHICH PASSED.

    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
    1 047 YR