BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1193379 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07402
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING LOW SODIUM RESULTS. USER REPORTED THE INITIAL SODIUM RESULTS FOR THE FOLLOWING FIVE PATIENT SAMPLES WHICH WERE QUESTIONED BY THE PHYSICIAN AND THEN REPEATED. PATIENT 1, INITIAL GAVE 129 MMOL/L; REPEAT GAVE 135 MMOL/L. PATIENT 2, INITIAL GAVE 126 MMOL/L; REPEAT GAVE 132 MMOL/L. PATIENT 3, INITIAL GAVE 126 MMOL/L; REPEAT GAVE 132 MMOL/L. PATIENT 4, INITIAL GAVE 128 MMOL/L; REPEAT GAVE 134 MMOL/L. PATIENT 5, INITIAL GAVE 126 MMOL/L; REPEAT GAVE 133 MMOL/L. USER STATED CORRECTED RESULTS WERE REPORTED. NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE DUE TO EVAPORATION OF THE INTERNAL STANDARD, AND REPLACED INTERNAL STANDARD. A FIELD CORRECTION FOR THIS ISSUE HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK