BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1193366 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07393
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED ERRONEOUS PHOSPHORUS AND CALCIUM RESULTS FOR TWO PATIENT SAMPLES. SAMPLE 1, INITIAL PHOSPHORUS 14.6 MG/DL, REPEAT 2.2 MG/DL. SAMPLE 2, INITIAL CALCIUM RESULT 4.6 MG/DL, REPEAT 9.4 MG/DL. NEITHER OF THE ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS CLEANER IN THE REAGENT PROBES. HE REPLACED THE CLEANER VALVE AND FLUSHED OUT THE PROBES. ON FOLLOW UP VISIT, HE DETERMINED THE V4 VALVE ON THE PIPETTE MODULE FOR THE RT1SR PROBE WAS NOT WORKING AND REPLACED IT. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK