BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3012598 · Received March 20, 2013

    Report

    Report Number
    1823260-2013-01678
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE SUBASSEMBLY- VACUUM LINE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. A CLEAR DISTINCTION OF THE PERFORMED ACTIONS VS. ROOT CAUSE ANALYSIS WAS NOT POSSIBLE. BASED ON THE REPORTED RESULTS, AN EFFECT OF THE PREANALYTICS CANNOT CLEARLY BE EXCLUDED. THE CHARACTER OF THE RESULTS IS TYPICAL FOR PROBLEMS WITH MIS-SAMPLING. THESE EFFECTS ARE CAUSED BY POOR SAMPLE QUALITY. PRE-ANALYTICAL FACTORS CAN INFLUENCE PATIENT TEST RESULTS. AN INSTRUMENT MALFUNCTION WAS NOT DETECTED.

    Description of Event or Problem · 1

    THE CUSTOMER HAD A PROBLEM WITH ION SELECTIVE ELECTRODE (ISE) STABILITY. THE CUSTOMER HAD A GOOD CALIBRATION AND QC, THEN CALIBRATION 4 HOURS LATER,CALIBRATION WOULD FAIL AND QC FOR SODIUM (NA) AND CHLORIDE (CL) WOULD BE OUT OF RANGE. THE ISSUE BEGAN THE EVENING OF (B)(6) 2013 AND CONTINUED OVER NIGHT, INTO (B)(6) 2013. THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR 46 PATIENTS OVER THIS TIME FRAME. OF THOSE 46, THREE SAMPLES HAD ERRONEOUS RESULTS FOR NA AND ONE SAMPLE HAD ERRONEOUS RESULTS FOR CL. ALL RESULTS ARE IN MMOL/L. PATIENT (B)(6) HAD AN INITIAL CL RESULT OF 91. THE SAMPLE WAS REPEATED ON A COBAS 6000 C501. THE REPEAT RESULT WAS 101. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 134. THE SAMPLE WAS REPEATED ON A COBAS 6000 C501. THE REPEAT RESULT WAS 141. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 128. THE SAMPLE WAS REPEATED ON A COBAS 6000 C501. THE REPEAT RESULT WAS 134. PATIENT (B)(6) HAD AN INITIAL NA RESULT OF 133. THE SAMPLE WAS REPEATED ON A COBAS 6000 C501. THE REPEAT RESULT WAS 141. THE INITIAL RESULTS FOR ALL FIVE PATIENTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DEEMED THE REPEAT RESULTS TO BE THE CORRECT RESULTS FOR THE SAMPLES AND ISSUED CORRECTED REPORTS. THERE WAS NO ADVERSE EVENT. THE LOT OF NA AND CL ELECTRODE IN USE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE SUSPECTED A CLOG. THE CUSTOMER HAD CHANGED A PROBE. THE FIELD SERVICE REPRESENTATIVE BACK FLUSHED THE TUBING, CORRECTED A HOLE IN THE VACUUM LINE, REPLACED A SECTION OF CELLS, AND PERFORMED A CELL BLANK. HE ALSO PERFORMED AN ISE CHECK. THE CUSTOMER PERFORMED CALIBRATION AND QC SEVERAL TIMES; WHICH WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116055 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1