BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1234073 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08151
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 9, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT CALCIUM RESULTS FOR ONE PT DURING ONE EVENING SHIFT. INITIAL RESULT GAVE 10.1 MG/DL. SAME SAMPLE REPEATED TWICE GAVE 9.0 AND 9.1 MG/DL. PT RESULT WAS NOT RELEASED UNTIL REPEATED. REPORTED RESULT WAS 9.0 MG/DL. PT WAS NOT ADVERSELY AFFECTED. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS I400+

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK