BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HITACHI 912

    MDR report key: 1780190 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08264
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS THEY WERE EXPERIENCING NOISE FLAGS AND GETTING ERRATIC ISE RESULTS. AS AN EXAMPLE THEY OBTAINED A PT POTASSIUM RESULT OF 5.2 MEQ/L AND WHEN REPEATED ON ANOTHER INSTRUMENT, THE RESULT WAS 4.4 MEQ/L. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP FOUND THE ISE UNIT WAS FAULTY AND REPAIRED THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HITACHI 912 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA