BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1063005 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04818
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. REPEAT TESTING OCCURRED IN 2008. PATIENT 1: INITIAL SODIUM GAVE 124 MMOL/L; REPEAT GAVE 135 MMOL/L. INITIAL RESULTS WERE REPORTED. PATIENTS NOT ADVERSELY AFFECTED. ALTHOUGH EXACT ROOT CAUSE WAS NOT DETERMINED THE FIELD SERVICE REPRESENTATIVE NOTED HE CLEANED THE ISE PATH, CHECKED SIPPER AND SAMPLE PROBES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    TWO PATIENT SAMPLES WITH DISCREPANT SODIUM RESULTS. REPEAT TESTING OCCURRED IN 2008. PATIENT 2, INITIAL SODIUM GAVE 128 MMOL/L; REPEAT GAVE 138 MMOL/L. INITIAL RESULTS WERE REPORTED. PATIENTS NOT ADVERSELY AFFECTED. ALTHOUGH EXACT ROOT CAUSE WAS NOT DETERMINED THE FIELD SERVICE REPRESENTATIVE NOTED HE CLEANED THE ISE PATH, CHECKED SLIPPER AND SAMPLE PROBES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    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
    2 UNK