BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE INDIRECT NA+ FOR GEN.2

    MDR report key: 2162982 · Received July 15, 2011

    Report

    Report Number
    1823260-2011-03752
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 31, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION DETERMINED THE ROOT CAUSE FOR THE ISSUE COULD BE A BAD CALIBRATION. AFTER REPLACEMENT OF THE REFERENCE ELECTRODE AND RECALIBRATION, THE ISSUE APPEARED TO BE RESOLVED. AS ADDITIONAL DATA WAS NOT PROVIDED, FURTHER INVESTIGATION WAS NOT POSSIBLE.

    Additional Manufacturer Narrative · 1

    OTHER ASSAYS RELATED TO THIS EVENT ARE REPORTED IN MEDWATCH REPORT WITH PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE-SODIUM RESULTS FOR OVER 100 PATIENT SAMPLES FROM THE COBAS 8000 ISE MODULE SERIAL NUMBER (B)(4) THAT WERE UP TO 10 UNITS LOWER WHEN COMPARED TO AN ABL ANALYZER. OF THE DATA PROVIDED, THE RESULTS FOR 106 PATIENT SAMPLES WERE DISCREPANT. THE REPEAT TESTING WAS PERFORMED ON A COBAS 6000 ANALYZER. NO DATA COULD BE PROVIDED FROM THE ABL ANALYZER.ALL RESULTS ARE IN MMOL/L. PATIENT SAMPLE 1 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 2 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 3 INITIAL RESULT WAS 128 AND THE REPEAT RESULT WAS 139. PATIENT SAMPLE 4 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 5 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 140. PATIENT SAMPLE 6 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 145. PATIENT SAMPLE 7 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 8 INITIAL RESULT WAS 135 AND THE REPEAT RESULT WAS 147. PATIENT SAMPLE 9 INITIAL RESULT WAS 128 AND THE REPEAT RESULT WAS 140. PATIENT SAMPLE 10 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 11 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 12 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 13 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 14 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 15 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 145. PATIENT SAMPLE 16 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 17 INITIAL RESULT WAS 127 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 18 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 19 INITIAL RESULT WAS 134 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 20 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 21 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 22 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 146. PATIENT SAMPLE 23 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 24 INITIAL RESULT WAS 128 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 25 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 140. PATIENT SAMPLE 26 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 140. PATIENT SAMPLE 27 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 28 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 29 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 30 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 31 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 32 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 33 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 34 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 35 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 36 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 37 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 38 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 39 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 40 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 41 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 42 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 43 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 44 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 45 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 46 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 47 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 48 INITIAL RESULT WAS 136 AND THE REPEAT RESULT WAS 147. PATIENT SAMPLE 49 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 50 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 51 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 52 INITIAL RESULT WAS 128 AND THE REPEAT RESULT WAS 140. PATIENT SAMPLE 53 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 54 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 55 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 56 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 57 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 145. PATIENT SAMPLE 58 INITIAL RESULT WAS 134 AND THE REPEAT RESULT WAS 146. PATIENT SAMPLE 59 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 60 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 61 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 62 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 63 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 145. PATIENT SAMPLE 64 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 65 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 66 INITIAL RESULT WAS 128 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 67 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 68 INITIAL RESULT WAS 139 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 69 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 70 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 71 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 72 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 73 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 74 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 75 INITIAL RESULT WAS 134 AND THE REPEAT RESULT WAS 145. PATIENT SAMPLE 76 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 77 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 78 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 79 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 80 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 146. PATIENT SAMPLE 81 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 140. PATIENT SAMPLE 82 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 83 INITIAL RESULT WAS 128 AND THE REPEAT RESULT WAS 139. PATIENT SAMPLE 84 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 145. PATIENT SAMPLE 85 INITIAL RESULT WAS 125 AND THE REPEAT RESULT WAS 137. PATIENT SAMPLE 86 INITIAL RESULT WAS 126 AND THE REPEAT RESULT WAS 139. PATIENT SAMPLE 87 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 88 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 89 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 145. PATIENT SAMPLE 90 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 91 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 92 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 145. PATIENT SAMPLE 93 INITIAL RESULT WAS 136 AND THE REPEAT RESULT WAS 146. PATIENT SAMPLE 94 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 95 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 145. PATIENT SAMPLE 96 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 143. PATIENT SAMPLE 97 INITIAL RESULT WAS 127 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 98 WAS FROM A (B)(6) MALE. THE INITIAL RESULT WAS 118 AND THE REPEAT RESULT WAS 129 WITH A DATA FLAG. PATIENT SAMPLE 99 INITIAL RESULT WAS 127 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 100 INITIAL RESULT WAS 127 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 101 INITIAL RESULT WAS 127 AND THE REPEAT RESULT WAS 139. PATIENT SAMPLE 102 INITIAL RESULT WAS 126 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 103 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 104 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 105 INITIAL RESULT WAS 126 AND THE REPEAT RESULT WAS 138. PATIENT SAMPLE 106 INITIAL RESULT WAS 129 AND THE REPEAT RESULT WAS 142. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED RESULTS WERE SENT FOR ABOUT 100 SAMPLES. NONE OF THE PATIENTS WERE TREATED OR ADVERSELY AFFECTED BASED ON THE ERRONEOUS RESULTS. THE PATIENT FOR SAMPLE 98 WAS INSTRUCTED TO GO TO THE ER BUT ENDED UP NOT GOING SINCE HIS GENERAL PRACTITIONER REQUESTED HE COME IN THE FOLLOWING MORNING AND BE REDRAWN. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS THE REFERENCE ELECTRODE AND REPLACED IT. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION AND QUALITY CONTROL WITH RESULTS THAT MET THE LABORATORY'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISE INDIRECT NA+ FOR GEN.2 ELECTRODE, ION SPECIFIC, SODIUM JGS ROCHE DIAGNOSTICS NA I8566

    Patients

    Seq Age Sex Outcome Treatment
    1