BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA (400) SYSTEM

    MDR report key: 1770583 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09183
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING INTERMITTENT DISCREPANT PATIENT RESULTS FOR CALCIUM AND CO2. PROVIDED ONLY FOUR PATIENT SAMPLES AS EXAMPLES. PATIENT 1, INITIAL CALCIUM GAVE 8.92 MG/DL, SAME SAMPLE REPEATED GAVE 9.66 MG/DL. PATIENT 2, INITIAL CALCIUM GAVE 6.49 MG/DL, SAME SAMPLE REPEATED GAVE 7.28 MG/DL. PATIENT 3, INITIAL CALCIUM GAVE 8.50 MG/DL, SAME SAMPLE REPEATED GAVE 9.60 MG/DL. PATIENT 4, INITIAL CO2 GAVE 35.3 MMOL/L, SAME SAMPLE REPEATED ON ANOTHER ANALYZER SAME METHOD GAVE 25.0 MMOL/L. INITIAL RESULTS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE THE CAUSE OF THE DISCREPANCY. PERFORMANCE TESTS PERFORMED, WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA (400) SYSTEM CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I400

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK