BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE SODIUM ELECTRODE

    MDR report key: 2990801 · Received March 5, 2013

    Report

    Report Number
    1823260-2013-01326
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K963627
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. AFTER THE EXCHANGE OF ALL ISE CONSUMABLES AND REAGENTS, IT IS IMPOSSIBLE TO EVALUATE THE REAL ROOT CAUSE OF THIS ISSUE. THE CALIBRATION REPORTS SHOW A GOOD PERFORMANCE. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT STARTING ON (B)(6) 2013, THEY WERE SEEING LOW ION SELECTIVE ELECTRODE (ISE) SODIUM VALUES ON ONE LEVEL OF CONTROL AND APPROXIMATELY 10 PATIENT SAMPLES WERE QUESTIONED. THE CUSTOMER PROVIDED DATA FOR EIGHT PATIENT SAMPLES AND INITIAL RESULTS FOR ALL EIGHT SAMPLES WERE FOUND TO BE ERRONEOUS WHEN TESTED ON A C111 INSTRUMENT. SAMPLES WERE SENT TO A HOSPITAL LABORATORY WHERE THEY WERE REPEATED ON A BECKMAN (B)(4) INSTRUMENT. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND CORRECTED REPORTS WERE ISSUED FOR THESE. SAMPLE ONE INITIALLY RESULTED AS 128 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AND RESULTED AS 136 MMOL/L. SAMPLE TWO, FROM A MALE, INITIALLY RESULTED AS 130 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AND RESULTED AS 138 MMOL/L. SAMPLE THREE, FROM A (B)(6) FEMALE BORN ON (B)(6) 1941, INITIALLY RESULTED AS 130 MMOL/L. THE SAMPLE WAS REPEATED AND RESULTED AS 138 MMOL/L. SAMPLE FOUR, FROM A (B)(6) FEMALE BORN ON (B)(6) 1982, INITIALLY RESULTED AS 130 MMOL/L. THE SAMPLE WAS REPEATED AND RESULTED AS 138 MMOL/L. SAMPLE FIVE, FROM A (B)(6) FEMALE BORN ON (B)(6) 1952, INITIALLY RESULTED AS 132 MMOL/L. THE SAMPLE WAS REPEATED AND RESULTED AS 139 MMOL/L. SAMPLE SIX, FROM A (B)(6) MALE BORN ON (B)(6) 1941, INITIALLY RESULTED AS 131 MMOL/L. THE SAMPLE WAS REPEATED AND RESULTED AS 140 MMOL/L. SAMPLE SEVEN, FROM A (B)(6) FEMALE BORN ON (B)(6) 1952, INITIALLY RESULTED AS 133 MMOL/L. THE SAMPLE WAS REPEATED AND RESULTED AS 141 MMOL/L. SAMPLE EIGHT, FROM A (B)(6) MALE BORN ON (B)(6) 1952, INITIALLY RESULTED AS 132 MMOL/L. THE SAMPLE WAS REPEATED AND RESULTED AS 142 MMOL/L. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THE EVENT. THE PHYSICIAN WHO WAS PROVIDED THE ERRONEOUS RESULTS WAS AWARE THAT THERE WAS AN ISSUE WITH ISE SODIUM RECOVERY ON THE C111 ANALYZER. THE C111 ANALYZER SERIAL NUMBER WAS (B)(4). THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WAS A FAILURE OF THE ISE SODIUM ELECTRODE. HE REPLACED ALL ELECTRODES, SYRINGE TIP, INDIRECT CALIBRATOR BOTTLE, REFERENCE SOLUTION BOTTLE, SAMPLE PROBE, AND MIXING TOWER O-RINGS. THE CUSTOMER MADE UP NEW QUALITY CONTROL MATERIAL. ALL ELECTRODES CALIBRATED AND QUALITY CONTROL RESULTS WERE OK. THE CUSTOMER REPEATED SOME PATIENT SAMPLES THAT INITIALLY HAD LOW ISE SODIUM RESULTS ON THE C111 ANALYZER AND THE REPEAT RESULTS CORRELATED WELL WITH THE RESULTS FROM THE OTHER LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93579 ISE SODIUM ELECTRODE ELECTRODE, ION SPECIFIC, SODIUM JGS ROCHE DIAGNOSTICS NA 21523544

    Patients

    Seq Age Sex Outcome Treatment
    1 LISINOPRIL - DAILY (PATIENT TWO)| LISINOPRIL - DAILY (PATIENT THREE)| ATORVASTIN - DAILY (PATIENT THREE)| ALDACTONE - DAILY (PATIENT ONE)| ALPRAZOLAM - DAILY (PATIENT TWO)| ALLOPURINOL - DAILY (PATIENT THREE)| IRON SUPPLEMENT (PATIENT THREE)| LASIX - DAILY (PATIENT ONE)| AGGRENOX - DAILY (PATIENT THREE)| MECLIDINE - DAILY (PATIENT THREE)| CITALOPRAM - DAILY (PATIENT THREE)| FLOMAX - DAILY (PATIENT TWO)| HYDROCODONE - EVERY 4-6 HOURS (PATIENT TWO)| MAGNESIUM - DAILY (PATIENT THREE)