BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1133408 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06363
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCED DISCREPANT SODIUM AND/OR POTASSIUM RESULTS FOR FOUR PATIENT SAMPLES. THE FOLLOWING PATIENT EXAMPLE WAS PROVIDED. INITIAL SODIUM GAVE 141 MMOL/L; REPEAT GAVE 130 MMOL/L. INITIAL POTASSIUM GAVE 4.0 MMOL/L; REPEAT GAVE 4.7 MMOL/L. INITIAL RESULTS WERE REPORTED. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE DIRTY/STICKING VALVES, AND REPLACED ISV6, ISV9 VALVES AND CLEANED ISV8 VALVE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    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