BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 1833994 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05428
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K071211
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE LOW SODIUM RESULTS FOR QUALITY CONTROL AND APPROXIMATELY 20 PATIENT SAMPLES OVER FIVE DAYS AFTER REPLACEMENT OF THE CHLORIDE ELECTRODE. OF THE DATA PROVIDED, THE SODIUM RESULT FOR ONE PATIENT SAMPLE GENERATED ON (B)(6) 2010 WAS DISCREPANT. THE INITIAL RESULT WAS 129 MMOL/L. THE SAMPLE WAS REPEATED ON THE I-STAT ANALYZER WITH A RESULT OF 135 MMOL/L. ERRONEOUS LOW RESULTS WERE REPORTED OUTSIDE THE LABORATORY FOR APPROXIMATELY TEN PATIENT SAMPLES. THE USER STATED NO PATIENTS WERE AFFECTED AS THE RESULTS WERE NOT UNBELIEVABLE. THE LOT NUMBER OF THE SODIUM ELECTRODE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS AGED ELECTRODES AND REPLACED THE SODIUM AND REFERENCE ELECTRODES. HE PERFORMED ELECTRODE SERVICE AND ACTIVATION. TO VERIFY THE ANALYZER OPERATION, HE RAN ISE PERFORMANCE CHECKS AND CALIBRATED SUCCESSFULLY. THE USER RAN SUCCESSFUL QUALITY CONTROL.

    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