BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1080652 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05652
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    FIVE PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. PATIENT 1, INITIAL RESULT GAVE 131 MMOL/L; REPEATED TWICE GIVING 131 AND 137 MMOL/L. PATIENT 2, INITIAL RESULT GAVE 127 MMOL/L; REPEATED TWICE GIVING 128 AND 136 MMOL/L. PATIENT 3, INITIAL RESULT 131 MMOL/L; REPEATED TWICE GIVING 131 AND 140 MMOL/L. PATIENT 4, INITIAL RESULT GAVE 127 MMOL/L; REPEATED TWICE GIVING 127 AND 136 MMOL/L. IN 2008: PATIENT 5, INITIAL RESULT GAVE 133 MMOL/L; REPEAT GAVE 140 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. ALTHOUGH THE EXACT ROOT CAUSE WAS UNDETERMINED, THE FIELD SERVICE REPRESENTATIVE NOTED HE REPLACED THE SODIUM ELECTRODE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK