BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE 9180

    MDR report key: 1024631 · Received April 3, 2008

    Report

    Report Number
    1823260-2008-02955
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    JFP
    PMA / PMN Number
    K050423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT GAVE 144 MMOL/L. SAME SAMPLE REPEATED THREE TIMES GIVING 141, 125 AND 138 MMOL/L RESPECTIVELY. NO ADVERSE EVENTS REPORTED. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISE 9180 BLOOD GAS ANALYZER - JFP JFP ROCHE DIAGNOSTICS CORP. ISE 9180

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK