BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 2842515 · Received November 21, 2012

    Report

    Report Number
    1823260-2012-05928
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 4, 2012
    Report Date
    February 27, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K071211
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE DATA ANALYZED, A PIPETTING PROBLEM COULD BE EXCLUDED. THE PROBLEM ON THE ANALYZER WAS NOT SYSTEMATIC. IT WAS NOTED THAT THE CUSTOMER WOULD SHUT DOWN THE INSTRUMENT FOR A FEW HOURS DURING THE DAY TO SAVE ENERGY WHICH IS NOT RECOMMENDED. THE CUSTOMER WAS ADVISED OF PROPER HANDLING OF CALIBRATORS AND QUALITY CONTROL MATERIALS. THE CUSTOMER WAS ADVISED TO IMPROVE THEIR ANALYZER MAINTENANCE AND MAINTENANCE FREQUENCY.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS ON THEIR COBAS C111 ANALYZER. THE CUSTOMER PROVIDED DATA FOR SIX PATIENTS, OF WHICH ONE HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S SAMPLE WAS TESTED FOUR TIMES, AND THE SODIUM RESULT WAS 118 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L. BASED ON THE LOW SODIUM RESULT, A SUBDURAL HEMATOMA WAS SUSPECTED FOR THE PATIENT. THE PATIENT HAD A CT MADE OF THE HEAD. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE SODIUM ELECTRODE LOT NUMBER WAS 21522044 AND THE EXPIRATION DATE WAS 11/16/2012. THE FIELD SERVICE REPRESENTATIVE REPLACED THE AFFECTED ISE MODULE. ALL ELECTRODES AND ISE REAGENTS WERE REPLACED. THE PRE-ANALYTICS IN THE LABORATORY WERE CHECKED AND THERE WAS NOTHING REMARKABLE. AFTER INITIALIZING AND CONDITIONING, CALIBRATION AND QUALITY CONTROLS WERE PERFORMED WITHOUT ANY PROBLEMS. ONE PATIENT MEASURED AFTER THE REPLACEMENT OF THE ISE MODULE GOT ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS C111 CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1