BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1030447 · Received April 17, 2008

    Report

    Report Number
    1823260-2008-03333
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 30, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED TOTAL PROTEIN RESULT THAT WAS REPORTED TO THE LABORATORY INFORMATION SYSTEM AS AN ALBUMIN RESULT. THE TOTAL PROTEIN RESULT OF 77.8 G/L WAS DISPLAYED AS AN ALBUMIN RESULT, BUT WAS ACTUALLY A TOTAL PROTEIN RESULT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE INVESTIGATIONAL UNIT VERIFIED THE CUSTOMER COMPLAINT. A COUNTER MEASURE HAS BEEN PROVIDED. CORRECTION TO ISSUE WILL BE RELEASED WITH SOFTWARE VERSION UPDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS MODULAR CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK