BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    917 DISK SYSTEM W/CO2

    MDR report key: 950927 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09876
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 29, 2007
    Report Date
    November 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCING DISCREPANT PATIENT ISE RESULTS SINCE 2007. ONLY FIVE PATIENT SAMPLES WERE PROVIDED AS EXAMPLES, WHICH OCCURRED ABOUT 3 DAYS LATER. PATIENT 1, FEMALE, INITIAL SODIUM GAVE 121 MEQ/L, REPEATED TWICE GAVE 139 & 141 MEQ/L RESPECTIVELY. PATIENT 2, MALE, INITIAL SODIUM GAVE 121 MEQ/L, REPEATED TWICE GAVE 139 MEQ/L EACH TIME. PATIENT 3, FEMALE, INITIAL SODIUM GAVE 122 MEQ/L, REPEATED THREE TIMES GAVE 138, 138 & 139 RESPECTIVELY. PATIENT 4, FEMALE, INITIAL SODIUM GAVE 131 MEQ/L; REPEAT GAVE 140 MEQ/L. PATIENT 5, MALE, INITIAL SODIUM GAVE 123 MEQ/L; REPEAT GAVE 144 MEQ/L. INITIAL POTASSIUM GAVE 4.2 MEQ/L; REPEAT GAVE 4.9 MEQ/L. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A PROBLEM WITH THE SAMPLE PROBE. CORRECTIVE MAINTENANCE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 917 DISK SYSTEM W/CO2 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS H917

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR