BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICAL CORE

    MDR report key: 1051419 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04199
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT POTASSIUM RESULTS. THREE PT EXAMPLES PROVIDED. PT 1, INITIAL RESULT 5.9 MMOL/L, REPEAT 2.7 MMOL/L. PT 2, INITIAL RESULT 6.1 MMOL/L, REPEAT 4.3 MMOL/L. PT 3, INITIAL RESULT 5.6 MMOL/L, REPEAT 3.8 MMOL/L. INITIAL RESULTS WERE REPORTED, THE PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE AN EMPTY DILUENT LINE NEAR THE VALVES. HE REPLACED TUBING TO BOTTLES, DILUENT 2W VALVE AND LIQUID FLOW SENSOR FOR DILUENT. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK