BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 1191547 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07213
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K071211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT SODIUM RESULTS FOR ONE PATIENT SAMPLE. INITIAL RESULT 125 MMOL/L, REPEATED IN 2008 GAVE 142 MMOL/L. THE INITIAL RESULT WAS NOT REPORTED. THE PATIENT WAS NOT TREATED BASED ON ERRONEOUS NA RESULT. THE INVESTIGATIONAL UNIT DID NOT VERIFY THE CUSTOMER COMPLAINT AND CONCLUDED THE CUSTOMER PERFORMS ELECTRODE SERVICE WEEKLY WHICH SHOULD BE DONE DAILY ACCORDING TO THE OPERATOR'S MANUAL. ADDITIONALLY, THE FIELD SERVICE REPRESENTATIVE TIGHTENED LOOSE FITTINGS ON BOTH PROBES. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK