BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1180820 · Received September 23, 2008

    Report

    Report Number
    1823260-2008-07110
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCE LEAK COMING OUT OF THE ANALYZER AND TO THE SURROUNDING AREA. USER STATED NO PROBLEMS HAVE BEEN NOTICED WITH PATIENT RESULTS. NO ONE SLIPPED OR FELL DUE TO LIQUID. THE FIELD SERVICE REPRESENTATIVE DETERMINED CONTAMINATION CAUSED A BLOCKED DRAIN FOR SAMPLE PROBE CLEANING RESULTING IN AN OVERFLOW OF FLUID. HE FLUSHED THE LINE TO CLEAN IT OUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK