BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1022494 · Received March 31, 2008

    Report

    Report Number
    1823260-2008-02882
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE PATIENT SAMPLES WITH DISCREPANT RESULTS FOR SODIUM, POTASSIUM OR ALBUMIN. PATIENT 1, INITIAL POTASSIUM RESULT 3.4 MMOL/L, REPEATED TWICE GIVING 4.2 AND 4.1 MMOL/L; INITIAL SODIUM RESULT 114 MMOL/L, REPEATED TWICE GIVING 138 MMOL/L BOTH TIMES. PATIENTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A PROBLEM WITH THE ISV8 AND ISV2 VALVES, AND REPLACED VALVES AS WELL AS RE-ALIGNED SAMPLE PROBE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    PATIENT 2: INITIAL POTASSIUM RESULT 3.8 MMOL/L, REPEATED TWICE GIVING 4.3 AND 4.4 MMOL/L; INITIAL SODIUM RESULT 124 MMOL/L, REPEATED TWICE GIVING 141 AND 143 MMOL/L. PATIENTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A PROBLEM WITH THE ISV8 AND ISV2 VALVES, AND REPLACED VALVES AS WELL AS RE-ALIGNED SAMPLE PROBE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 3

    PATIENT 3: INITIAL ALBUMIN RESULT 4.5 G/DL, REPEAT GAVE 3.9 G/DL. INITIAL RESULTS WERE REPORTED. PATIENTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A PROBLEM WITH THE ISV8 AND ISV2 VALVES, AND REPLACED VALVES AS WELL AS RE-ALIGNED SAMPLE PROBE. 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 61 YR
    2 75 YR
    3 73 YR