BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2461677 · Received February 20, 2012

    Report

    Report Number
    1823260-2012-01005
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    February 4, 2012
    Report Date
    March 22, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTICED THE ISE DILUENT ON THE C501 WAS SHOWING FULL ON (B)(6) 2012. THE CUSTOMER PROVIDED DATA FOR AN ADDITIONAL 76 PATIENTS WITH QUESTIONABLE SODIUM, POTASSIUM, AND CHLORIDE RESULTS, OF WHICH THERE WERE 72 DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. PATIENT 1 HAD AN INITIAL SODIUM RESULT OF 121 MEQ/ML. THE REPEAT RESULT WAS 131 MEQ/ML. PATIENT 2 HAD AN INITIAL SODIUM RESULT OF 120 MEQ/ML. THE REPEAT RESULT WAS 131 MEQ/ML. PATIENT 3 HAD AN INITIAL SODIUM RESULT OF 125 MEQ/ML. THE REPEAT RESULT WAS 137 MEQ/ML. PATIENT 3 HAD AN INITIAL CHLORIDE RESULT OF 95 MEQ/ML. THE REPEAT RESULT WAS 106 MEQ/ML. PATIENT 4 HAD AN INITIAL SODIUM RESULT OF 122 MEQ/ML. THE REPEAT RESULT WAS 131 MEQ/ML. PATIENT 5 HAD AN INITIAL SODIUM RESULT OF 127 MEQ/ML. THE REPEAT RESULT WAS 134 MEQ/ML. PATIENT 6 HAD AN INITIAL SODIUM RESULT OF 131 MEQ/ML. THE REPEAT RESULT WAS 139 MEQ/ML. PATIENT 7 HAD AN INITIAL SODIUM RESULT OF 130 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML. PATIENT 8 HAD AN INITIAL SODIUM RESULT OF 121 MEQ/ML. THE REPEAT RESULT WAS 132 MEQ/ML. PATIENT 8 HAD AN INITIAL POTASSIUM RESULT OF 5.3 MEQ/ML. THE REPEAT RESULT WAS 5.8 MEQ/ML. PATIENT 9 HAD AN INITIAL SODIUM RESULT OF 139 MEQ/ML. THE REPEAT RESULT WAS 147 MEQ/ML. PATIENT 9 HAD AN INITIAL CHLORIDE RESULT OF 99 MEQ/ML. THE REPEAT RESULT WAS 109 MEQ/ML. PATIENT 10 HAD AN INITIAL SODIUM RESULT OF 128 MEQ/ML. THE REPEAT RESULT WAS 134 MEQ/ML. PATIENT 11 HAD AN INITIAL SODIUM RESULT OF 132 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML. PATIENT 12 HAD AN INITIAL SODIUM RESULT OF 125 MEQ/ML. THE REPEAT RESULT WAS 131 MEQ/ML. PATIENT 13 HAD AN INITIAL SODIUM RESULT OF 128 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML. PATIENT 14 HAD AN INITIAL SODIUM RESULT OF 125 MEQ/ML. THE REPEAT RESULT WAS 131 MEQ/ML. PATIENT 15 HAD AN INITIAL SODIUM RESULT OF 130 MEQ/ML. THE REPEAT RESULT WAS 137 MEQ/ML. PATIENT 16 HAD AN INITIAL SODIUM RESULT OF 131 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML. PATIENT 17 HAD AN INITIAL SODIUM RESULT OF 125 MEQ/ML. THE REPEAT RESULT WAS 134 MEQ/ML. PATIENT 17 HAD AN INITIAL POTASSIUM RESULT OF 4.2 MEQ/ML. THE REPEAT RESULT WAS 4.7 MEQ/ML. PATIENT 18 HAD AN INITIAL SODIUM RESULT OF 134 MEQ/ML. THE REPEAT RESULT WAS 142 MEQ/ML. PATIENT 18 HAD AN INITIAL POTASSIUM RESULT OF 3.5 MEQ/ML. THE REPEAT RESULT WAS 4.2 MEQ/ML. PATIENT 19 HAD AN INITIAL SODIUM RESULT OF 126 MEQ/ML. THE REPEAT RESULT WAS 134 MEQ/ML. PATIENT 20 HAD AN INITIAL SODIUM RESULT OF 130 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML. PATIENT 21 HAD AN INITIAL SODIUM RESULT OF 128 MEQ/ML. THE REPEAT RESULT WAS 136 MEQ/ML. PATIENT 22 HAD AN INITIAL SODIUM RESULT OF 124 MEQ/ML. THE REPEAT RESULT WAS 133 MEQ/ML. PATIENT 23 HAD AN INITIAL SODIUM RESULT OF 129 MEQ/ML. THE REPEAT RESULT WAS 136 MEQ/ML. PATIENT 24 HAD AN INITIAL SODIUM RESULT OF 140 MEQ/ML. THE REPEAT RESULT WAS 146 MEQ/ML. PATIENT 25 HAD AN INITIAL SODIUM RESULT OF 129 MEQ/ML. THE REPEAT RESULT WAS 136 MEQ/ML. PATIENT 26 HAD AN INITIAL SODIUM RESULT OF 137 MEQ/ML. THE REPEAT RESULT WAS 149 MEQ/ML. PATIENT 26 HAD AN INITIAL CHLORIDE RESULT OF 105 MEQ/ML. THE REPEAT RESULT WAS 116 MEQ/ML. PATIENT 27 HAD AN INITIAL SODIUM RESULT OF 148 MEQ/ML. THE REPEAT RESULT WAS 155 MEQ/ML. PATIENT 28 HAD AN INITIAL SODIUM RESULT OF 134 MEQ/ML. THE REPEAT RESULT WAS 142 MEQ/ML. PATIENT 29 HAD AN INITIAL SODIUM RESULT OF 129 MEQ/ML. THE REPEAT RESULT WAS 137 MEQ/ML. PATIENT 30 HAD AN INITIAL SODIUM RESULT OF 134 MEQ/ML. THE REPEAT RESULT WAS 142 MEQ/ML. PATIENT 30 HAD AN INITIAL POTASSIUM RESULT OF 3.5 MEQ/ML. THE REPEAT RESULT WAS 4.1 MEQ/ML. PATIENT 31 HAD AN INITIAL SODIUM RESULT OF 121 MEQ/ML. THE REPEAT RESULT WAS 131 MEQ/ML. PATIENT 32 HAD AN INITIAL POTASSIUM RESULT OF 6.7 MEQ/ML. THE REPEAT RESULT WAS 3.9 MEQ/ML. PATIENT 33 HAD AN INITIAL SODIUM RESULT OF 129 MEQ/ML. THE REPEAT RESULT WAS 135 MEQ/ML. PATIENT 34 HAD AN INITIAL SODIUM RESULT OF 126 MEQ/ML. THE REPEAT RESULT WAS 136 MEQ/ML. PATIENT 34 HAD AN INITIAL POTASSIUM RESULT OF 4.4 MEQ/ML. THE REPEAT RESULT WAS 4.9 MEQ/ML. PATIENT 35 HAD AN INITIAL SODIUM RESULT OF 131 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML. PATIENT 36 HAD AN INITIAL SODIUM RESULT OF 132 MEQ/ML. THE REPEAT RESULT WAS 140 MEQ/ML. PATIENT 37 HAD AN INITIAL SODIUM RESULT OF 130 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML. PATIENT 38 HAD AN INITIAL SODIUM RESULT OF 129 MEQ/ML. THE REPEAT RESULT WAS 137 MEQ/ML. PATIENT 39 HAD AN INITIAL SODIUM RESULT OF 142 MEQ/ML. THE REPEAT RESULT WAS 148 MEQ/ML. PATIENT 40 HAD AN INITIAL SODIUM RESULT OF 134 MEQ/ML. THE REPEAT RESULT WAS 140 MEQ/ML. PATIENT 41 HAD AN INITIAL SODIUM RESULT OF 128 MEQ/ML. THE REPEAT RESULT WAS 139 MEQ/ML. PATIENT 42 HAD AN INITIAL SODIUM RESULT OF 127 MEQ/ML. THE REPEAT RESULT WAS 137 MEQ/ML. PATIENT 43 HAD AN INITIAL SODIUM RESULT OF 125 MEQ/ML. THE REPEAT RESULT WAS 134 MEQ/ML. PATIENT 44 HAD AN INITIAL SODIUM RESULT OF 125 MEQ/ML. THE REPEAT RESULT WAS 133 MEQ/ML. PATIENT 45 HAD AN INITIAL SODIUM RESULT OF 133 MEQ/ML. THE REPEAT RESULT WAS 141 MEQ/ML. PATIENT 45 HAD AN INITIAL POTASSIUM RESULT OF 3.6 MEQ/ML. THE REPEAT RESULT WAS 4.1 MEQ/ML. PATIENT 46 HAD AN INITIAL SODIUM RESULT OF 128 MEQ/ML. THE REPEAT RESULT WAS 135 MEQ/ML. PATIENT 47 HAD AN INITIAL SODIUM RESULT OF 128 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML. PATIENT 48 HAD AN INITIAL SODIUM RESULT OF 134 MEQ/ML. THE REPEAT RESULT WAS 140 MEQ/ML. PATIENT 49 HAD AN INITIAL SODIUM RESULT OF 126 MEQ/ML. THE REPEAT RESULT WAS 133 MEQ/ML. PATIENT 50 HAD AN INITIAL SODIUM RESULT OF 128 MEQ/ML. THE REPEAT RESULT WAS 137 MEQ/ML. PATIENT 51 HAD AN INITIAL SODIUM RESULT OF 131 MEQ/ML. THE REPEAT RESULT WAS 140 MEQ/ML. PATIENT 52 HAD AN INITIAL SODIUM RESULT OF 130 MEQ/ML. THE REPEAT RESULT WAS 139 MEQ/ML. PATIENT 53 HAD AN INITIAL SODIUM RESULT OF 132 MEQ/ML. THE REPEAT RESULT WAS 140 MEQ/ML. PATIENT 54 HAD AN INITIAL SODIUM RESULT OF 131 MEQ/ML. THE REPEAT RESULT WAS 139 MEQ/ML. PATIENT 55 HAD AN INITIAL SODIUM RESULT OF 133 MEQ/ML. THE REPEAT RESULT WAS 139 MEQ/ML. PATIENT 56 HAD AN INITIAL SODIUM RESULT OF 129 MEQ/ML. THE REPEAT RESULT WAS 137 MEQ/ML. PATIENT 57 HAD AN INITIAL SODIUM RESULT OF 131 MEQ/ML. THE REPEAT RESULT WAS 139 MEQ/ML. PATIENT 58 HAD AN INITIAL CHLORIDE RESULT OF 87 MEQ/ML. THE REPEAT RESULT WAS 101 MEQ/ML. PATIENT 59 HAD AN INITIAL SODIUM RESULT OF 128 MEQ/ML. THE REPEAT RESULT WAS 135 MEQ/ML. PATIENT 60 HAD AN INITIAL SODIUM RESULT OF 124 MEQ/ML. THE REPEAT RESULT WAS 134 MEQ/ML. PATIENT 61 HAD AN INITIAL SODIUM RESULT OF 127 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML. PATIENT 62 HAD AN INITIAL SODIUM RESULT OF 131 MEQ/ML. THE REPEAT RESULT WAS 137 MEQ/ML. PATIENT 63 HAD AN INITIAL SODIUM RESULT OF 132 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM, POTASSIUM, AND CHLORIDE RESULTS ON THEIR C501 ANALYZER. THE CUSTOMER STATED THE ISE DILUENT ON THE C501 WAS SHOWING FULL ON (B)(6) 2012, BUT WAS REALLY EMPTY. THE CUSTOMER HAD ERRONEOUS ISE RESULTS THAT HE FEELS WERE CAUSED BY THIS ISSUE. THE CUSTOMER STATED THERE WERE MORE THAN 80 CORRECTED REPORTS THAT HAD TO BE SENT. THE CUSTOMER PROVIDED NINE PATIENT RESULTS THAT WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. REPEAT TESTING WAS PERFORMED ON ANOTHER C501 ANALYZER, SERIAL NUMBER (B)(4). THE FIRST PATIENT'S INITIAL SODIUM RESULT WAS 120 MEQ/ML. THE REPEAT RESULT WAS 131 MEQ/ML. THE SECOND PATIENT'S INITIAL SODIUM RESULT WAS 130 MEQ/ML. THE REPEAT RESULT WAS 138 MEQ/ML. THE THIRD PATIENT'S INITIAL SODIUM RESULT WAS 122 MEQ/ML. THE REPEAT RESULT WAS 131 MEQ/ML. THE FOURTH PATIENT'S INITIAL SODIUM RESULT WAS 127 MEQ/ML. THE REPEAT RESULT WAS 134 MEQ/ML. THE FIFTH PATIENT'S INITIAL SODIUM RESULT WAS 125 MEQ/ML. THE REPEAT RESULT WAS 137 MEQ/ML. THE FIFTH PATIENT'S INITIAL CHLORIDE RESULT WAS 95 MEQ/ML. THE REPEAT RESULT WAS 106 MEQ/ML. THE SIXTH PATIENT'S INITIAL POTASSIUM RESULT WAS 5.3 MEQ/ML. THE REPEAT RESULT WAS 5.8 MEQ/ML. THE SEVENTH PATIENT'S INITIAL SODIUM RESULT WAS 121 MEQ/ML. THE REPEAT RESULT WAS 131 MEQ/ML. THE EIGHTH PATIENT'S INITIAL SODIUM RESULT WAS 131 MEQ/ML. THE REPEAT RESULT WAS 139 MEQ/ML. THE CUSTOMER CONSIDERED THE REPEAT RESULTS TO BE CORRECT AND THEY WERE ISSUED AS CORRECTED REPORTS. THERE WERE NO ADVERSE EVENTS. THE SODIUM, POTASSIUM, AND CHLORIDE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND AN ISSUE WITH THE ISE REAGENT PROBE ALIGNMENT. THEN HE ADJUSTED THE ISE REAGENT PROBE. HE RAN CALIBRATION AND QUALITY CONTROL TWICE WITH RESULTS WITHIN SPECIFICATION. HE RAN A PRECISION CHECK WITH PASSING RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1