BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 4000 C (311) STAND ALONE SYSTEM

    MDR report key: 7120798 · Received December 15, 2017

    Report

    Report Number
    1823260-2017-02954
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    December 4, 2017
    Report Date
    January 23, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CHANGED THE ELECTRODES ON THE ANALYZER. THE CUSTOMER HAS ALSO ADDED AN ADDITIONAL WASH DAILY USING POOLED SERUM AS THEY BELIEVE THE ELECTRODES AND TUBING ARE GETTING TOO CLEAN SINCE THEY ARE A LOW VOLUME LABORATORY. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE ISSUE MAY BE RELATED TO SAMPLE QUALITY, ISE/REFERENCE FLOW RELATED PROBLEMS, CALIBRATION ERROR, CONTAMINATION, OR SOME OTHER USE ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR FIVE PATIENT SAMPLES TESTED FOR ISE INDIRECT NA FOR GEN.2 (SODIUM) ON A COBAS 4000 C (311) STAND ALONE SYSTEM - C311. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE PHYSICIAN NOTICED A TREND IN LOW RESULTS. THE TEST WAS CALIBRATED AND THE SAMPLES WERE REPEATED AFTER CALIBRATION. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE FIRST SAMPLE INITIALLY RESULTED AS 130 MMOL/L AND REPEATED AS 137 MMOL/L. THE SECOND SAMPLE, FROM A (B)(6) FEMALE, INITIALLY RESULTED AS 127 MMOL/L AND REPEATED AS 135 MMOL/L. THE THIRD SAMPLE, FROM A (B)(6) FEMALE, INITIALLY RESULTED AS 133 MMOL/L AND REPEATED AS 141 MMOL/L. THE FOURTH SAMPLE, FROM A (B)(6) FEMALE, INITIALLY RESULTED AS 131 MMOL/L AND REPEATED AS 143 MMOL/L. THE FIFTH SAMPLE, FROM A (B)(6) MALE, INITIALLY RESULTED AS 133 MMOL/L AND REPEATED AS 140 MMOL/L. THE FIRST PATIENT AND THE FIFTH PATIENT WERE ADMITTED TO THE HOSPITAL BASED ON THE ERRONEOUS RESULTS. IT WAS ASKED, BUT IT IS NOT KNOWN IF THESE PATIENTS WERE ADVERSELY AFFECTED DUE TO BEING HOSPITALIZED. FOR ALL PATIENTS, THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER DETERMINED THAT THE SAMPLE PROBE WAS NOT SPRINGING UP AND DOWN. HE REMOVED AND ADJUSTED THE SAMPLE PROBE FOR CORRECT SPRING ACTION. AS A PREVENTIVE MEASURE, HE CLEANED THE ISE FLOWPATH, REPLACED AND CONDITIONED THE ISE PINCH VALVE TUBE, REMOVED ALL CARTRIDGES AND CLEANED THE CARTRIDGE CRADLE, CHANGED SYSTEM REAGENTS, PERFORMED PROBE ADJUSTMENTS, CLEANED THE ISE WASTE FITTING, CLEANED A SYSTEM REAGENT FILTER, CHECKED THE SYRINGES, AND CHECKED THE RINSE MECHANISM. HE SUCCESSFULLY PERFORMED MULTIPLE ISE CALIBRATIONS AND RAN ACCEPTABLE CONTROLS. HE RAN ACCEPTABLE ISE CHECKS AND A PRECISION CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901085 COBAS 4000 C (311) STAND ALONE SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C311 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR