BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA I400 PLUS

    MDR report key: 1030441 · Received April 17, 2008

    Report

    Report Number
    1823260-2008-03330
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH DISCREPANT CALCIUM RESULTS. INITIAL RESULT 14.1 MG/DL, SAME SAMPLE REPEATED GAVE RESULT OF 8.7 MG/DL. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCY. THE SYSTEM WAS BLEACHED AND PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA I400 PLUS CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I400+

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR