BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE INDIRECT NA+ FOR GEN.2

    MDR report key: 2112745 · Received June 3, 2011

    Report

    Report Number
    1823260-2011-02992
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 17, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION, NO INSTRUMENT MALFUNCTION COULD BE DETECTED AND NO SPECIFIC CAUSE COULD BE IDENTIFIED. THE OBSERVED DIFFERENCE FOR THE SAMPLES MIGHT HAVE BEEN CAUSED BY A CUSTOMER ERROR. IT WAS DETERMINED THE CUSTOMER WAS USING EXPIRED ELECTRODES WHICH HAD BEEN INSTALLED FOR MORE THAN TWO MONTHS. EVALUATION OF THE CALIBRATION DATA SHOWED THE CUSTOMER MOST PROBABLY REUSED THE ISE STANDARDS, WHICH PER PRODUCT LABELING IS FOR SINGLE USE ONLY. ACCORDING TO INFORMATION GIVEN THERE WERE NO ACTIONS TAKEN BASED ON THE RESULTS REPORTED FOR THE PATIENTS.

    Description of Event or Problem · 1

    THE USER DISCOVERED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS WERE GENERATED FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES FROM THE COBAS 4000 C311 ANALYZER SERIAL NUMBER (B)(4). ALL RESULTS ARE IN MMOL/L. ONE PATIENT HAD AN INITIAL RESULT OF 122 REPORTED OUTSIDE THE LABORATORY AND ON (B)(6) 2011 THE RESULT WAS QUESTIONED AS TOO LOW. THE USER REPEATED TESTING WITH A RESULT OF 122, BUT THIS RESULT WAS CONSIDERED TO NOT FIT THE CLINICAL PICTURE OF THE PATIENT. THE USER REPLACED THE ELECTRODES, RAN CALIBRATION AND QUALITY CONTROL, THEN REPEATED THE PATIENT SAMPLE. THE RESULT WAS THEN 130 WHICH WAS CONSIDERED TO BE IN LINE WITH THE CLINICAL SYMPTOMS OF THE PATIENT. THE USER THEN RETESTED ALL PATIENT SAMPLES THAT HAD SODIUM TESTING BETWEEN (B)(6) 2011. THE USER PROVIDED DATA FOR 48 PATIENT SAMPLES, OF WHICH THE RESULTS FOR THE FOLLOWING SAMPLES WERE DISCREPANT. THE FOLLOWING PATIENT SAMPLES WERE INITIALLY TESTED ON (B)(6) 2011. PATIENT SAMPLE 2 INITIAL RESULT WAS 133, THE REPEAT RESULT WAS 140. PATIENT SAMPLE 3 INITIAL RESULT WAS 134, THE REPEAT RESULT WAS 142. PATIENT SAMPLE 4 INITIAL RESULT WAS 130, THE REPEAT RESULT WAS 137. PATIENT SAMPLE 5 INITIAL RESULT WAS 133, THE REPEAT RESULT WAS 140. PATIENT SAMPLE 6 INITIAL RESULT WAS 129, THE REPEAT RESULT WAS 137. PATIENT SAMPLE 7 INITIAL RESULT WAS 128, THE REPEAT RESULT WAS 135. PATIENT SAMPLE 8 INITIAL RESULT WAS 130, THE REPEAT RESULT WAS 138. PATIENT SAMPLE 9 INITIAL RESULT WAS 133, THE REPEAT RESULT WAS 141. PATIENT SAMPLE 10 INITIAL RESULT WAS 132, THE REPEAT RESULT WAS 139. PATIENT SAMPLE 11 INITIAL RESULT WAS 132, THE REPEAT RESULT WAS 140. PATIENT SAMPLE 12 INITIAL RESULT WAS 130, THE REPEAT RESULT WAS 137. PATIENT SAMPLE 13 INITIAL RESULT WAS 126, THE REPEAT RESULT WAS 134. THE FOLLOWING PATIENT SAMPLES WERE INITIALLY TESTED ON (B)(6) 2011. PATIENT SAMPLE 14 INITIAL RESULT WAS 132, THE REPEAT RESULT WAS 139. PATIENT SAMPLE 15 INITIAL RESULT WAS 133, THE REPEAT RESULT WAS 140. PATIENT SAMPLE 16 INITIAL RESULT WAS 131, THE REPEAT RESULT WAS 137. PATIENT SAMPLE 17 INITIAL RESULT WAS 129, THE REPEAT RESULT WAS 136. PATIENT SAMPLE 18 INITIAL RESULT WAS 134, THE REPEAT RESULT WAS 140. THE FOLLOWING PATIENT SAMPLES WERE INITIALLY TESTED ON (B)(6) 2011. PATIENT SAMPLE 19 INITIAL RESULT WAS 131, THE REPEAT RESULT WAS 142. PATIENT SAMPLE 20 INITIAL RESULT WAS 127, THE REPEAT RESULT WAS 140. PATIENT SAMPLE 21 INITIAL RESULT WAS 130, THE REPEAT RESULT WAS 141. PATIENT SAMPLE 22 INITIAL RESULT WAS 128, THE REPEAT RESULT WAS 140. PATIENT SAMPLE 23 INITIAL RESULT WAS 128, THE REPEAT RESULT WAS 140. PATIENT SAMPLE 24 INITIAL RESULT WAS 128, THE REPEAT RESULT WAS 141. PATIENT SAMPLE 25 INITIAL RESULT WAS 129, THE REPEAT RESULT WAS 141. PATIENT SAMPLE 26 INITIAL RESULT WAS 129, THE REPEAT RESULT WAS 138. PATIENT SAMPLE 27 INITIAL RESULT WAS 122, THE REPEAT RESULT WAS 133. PATIENT SAMPLE 28 INITIAL RESULT WAS 129, THE REPEAT RESULT WAS 141. PATIENT SAMPLE 29 INITIAL RESULT WAS 131, THE REPEAT RESULT WAS 142. PATIENT SAMPLE 30 INITIAL RESULT WAS 129, THE REPEAT RESULT WAS 139. PATIENT SAMPLE 31 INITIAL RESULT WAS 132, THE REPEAT RESULT WAS 140. PATIENT SAMPLE 32 INITIAL RESULT WAS 131, THE REPEAT RESULT WAS 140. THE INITIAL RESULTS FOR ALL SAMPLES WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT. UPON EVALUATION OF THE ISE SYSTEM, THE FIELD SERVICE REPRESENTATIVE FOUND NO FAULT WITH THE SYSTEM. HE REPLACED THE REFERENCE ELECTRODE AND CHECKED THE ADJUSTMENT OF THE SAMPLE PROBE. TO VERIFY THE ANALYZER OPERATION, HE RAN ISE CHECKS WITH ALL RESULTS WITHIN SPECIFICATION.

    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 H91

    Patients

    Seq Age Sex Outcome Treatment
    1