BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1203483 · Received October 17, 2008

    Report

    Report Number
    1823260-2008-07726
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 17, 2008
    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

    USER EXPERIENCED ERRATIC RESULTS FOR ELEVEN PTS. ONLY ONE PT EXAMPLE WAS PROVIDED. INITIAL POTASSIUM RESULT 3.2 MEQ/L, REPEAT 4.4 MEQ/L. THERE WERE NO INCORRECT RESULTS REPORTED AND THERE WERE NO KNOWN DELAYS IN TREATMENT. THE FIELD SERVICE REP DETERMINED A CLOTTED SAMPLE WHICH PASSED THROUGH THE SYSTEM AT THE ISE MODULE AND ONTO THE P MODULE WAS THE CAUSE. HE CLEANED THE COVERS FROM THE RACK AREA TO ISE#1 AND AT THE RINSE STATION, HE ALSO FLUSHED THE FLOW PATH ON BOTH ISE MODULES. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK