BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1030603 · Received April 16, 2008

    Report

    Report Number
    1823260-2008-03284
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 23, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT EXPERIENCING GETTING LOW PATIENT BICARBONATE (CO2) RESULTS, WHICH ARE HIGHER WHEN REPEATED. ONLY THE FOLLOWING TWO PATIENT EXAMPLES WERE PROVIDED: PATIENT 1, INITIAL CO2 GAVE 11 MMOL/L. SAMPLE REPEATED TWICE GIVING 20 AND 23 MMOL/L. NO INFORMATION PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE OF THE DISCREPANCIES TO BE DUE TO CONTAMINATION OF THE INTERNAL WATER SYSTEM, AND DECONTAMINATED SYSTEM. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    ACCOUNT EXPERIENCING GETTING LOW PATIENT BICARBONATE (CO2) RESULTS, WHICH ARE HIGHER WHEN REPEATED. ONLY THE FOLLOWING TWO PATIENT EXAMPLES WERE PROVIDED. PATIENT 2: OCCURRED IN 2008, INITIAL CO2 GAVE 12 MMOL/L; REPEAT GAVE 26 MMOL/L. NO INFORMATION PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE OF THE DISCREPANCIES TO BE DUE TO CONTAMINATION OF THE INTERNAL WATER SYSTEM. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS P MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR
    2 67 YR