BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1193396 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07436
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 15, 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
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING DISCREPANT CK RESULTS FOR ONE PATIENT IN 2008, INITIAL RESULT WAS 12 U/L, REPEAT RESULT WAS 6 U/L. ERRONEOUS RESULTS WAS NOT REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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 27 YR PREDNISONE - 20 MG TID| LASIX| BENICAR| CELLCEPT - 1500 MG BID| TOPROL| PROTONIX| PROZAC| PLAQUENIL