BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1193393 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07434
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 18, 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
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT IGM RESULTS FOR ONE PT SAMPLE. INITIAL RESULT 7 MG/DL, REPEAT 11 MG/DL. INITIAL RESULT WAS REPORTED. NO INFO WAS PROVIDED TO DETERMINE IF ANY ADVERSE EVENTS OCCURRED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO FIND A CAUSE, BUT NOTED HE CHECKED THE ANALYZER. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK