BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS MIRA ISE MODULE

    MDR report key: 1040403 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03830
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K920402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT 132 MMOL/L, REPEAT 138 MMOL/L. INITIAL RESULT WAS NOT REPORTED. THE USER CLEANED THE MIX TOWER AND ISE TUBING WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS MIRA ISE MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS MIRA ISE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK