BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1180817 · Received September 23, 2008

    Report

    Report Number
    1823260-2008-07107
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING DISCREPANT RESULTS FOR SODIUM. FOUR PATIENT SAMPLES ARE AFFECTED. REPEAT TESTING WAS PERFORMED ON OTHER ANALYZER. INITIAL RESULT 133 MMOL/L, REPEAT 140 MMOL/L. REPEAT RESULTS WERE REPORTED FOR ALL SAMPLES. THE FIELD SERVICE REP DETERMINED MIX DRY PRESSURE WAS LOW AND THE MIX TOWER WAS CLOGGED. HE REPLACED THE MIX TOWER AND ADJUSTED THE MIX DRY PRESSURE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    USER RECEIVING DISCREPANT RESULTS FOR SODIUM. FOUR PATIENT SAMPLES ARE AFFECTED. REPEAT TESTING WAS PERFORMED ON OTHER ANALYZER. INITIAL RESULT 127 MMOL/L, REPEAT 134 MMOL/L. REPEAT RESULTS WERE REPORTED FOR ALL SAMPLES. THE FIELD SERVICE REP DETERMINED MIX DRY PRESSURE WAS LOW AND THE MIX TOWER WAS CLOGGED. HE REPLACED THE MIX TOWER AND ADJUSTED THE MIX DRY PRESSURE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 3

    USER RECEIVING DISCREPANT RESULTS FOR SODIUM. FOUR PATIENT SAMPLES ARE AFFECTED. REPEAT TESTING WAS PERFORMED ON OTHER ANALYZER. INITIAL RESULT 131 MMOL/L, REPEAT 139 MMOL/L. REPEAT RESULTS WERE REPORTED FOR ALL SAMPLES. THE FIELD SERVICE REP DETERMINED MIX DRY PRESSURE WAS LOW AND THE MIX TOWER WAS CLOGGED. HE REPLACED THE MIX TOWER AND ADJUSTED THE MIX DRY PRESSURE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 4

    USER RECEIVING DISCREPANT RESULTS FOR SODIUM. FOUR PATIENT SAMPLES ARE AFFECTED. REPEAT TESTING WAS PERFORMED ON OTHER ANALYZER. INITIAL RESULT 133 MMOL/L, REPEAT 142 MMOL/L. REPEAT RESULTS WERE REPORTED FOR ALL SAMPLES. THE FIELD SERVICE REP DETERMINED MIX DRY PRESSURE WAS LOW AND THE MIX TOWER WAS CLOGGED. HE REPLACED THE MIX TOWER AND ADJUSTED THE MIX DRY PRESSURE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR
    2 84 YR
    3 UNK
    4 69 YR