BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1018592 · Received March 21, 2008

    Report

    Report Number
    1823260-2008-02695
    Event Type
    Malfunction
    Date Received
    March 21, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTED EXPERIENCING DISCREPANT SODIUM RESULTS. THE FOLLOWING FORTY-FIVE PATIENT EXAMPLES WERE PROVIDED: PATIENT #, INITIAL/REPEAT (ALL UNITS MMOL/L). #1, 127/133; #2, 128/136; #3, 128/135; #4, 133/141; #5, 129/136; #6, 132/138; #7, 134/141; #8, 128/137; #9 133/141, #10, 129/136; #11, 131/138; #12, 132/138; #13, 134/141 #14,132/138; #15,127/134; #16,126/133 #17,132/142; #18,134/140; #19, 132/140; #20, 129/136; #21, 130/137; #22,131/138 #23, 123/130; #24, 128/135; #25, 129/136; #26, 130/137; #27, 132/138; #28, 128/135; #29, 133/139; #30, 133/139; #31, 133/140; #32, 131/140; #33, 126/134; #34, 130/138; #35, 133/139; #36, 126/132; #37, 133/139; #38, 129/139; #39, 128/135; #40, 130/137; #41, 128/135; #42, 136/143; #43, 133/141; #44, 128/137; #45, 132/140. THE INITIAL RESULTS WERE REPORTED, THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE BUT NOTED HE REPLACED SIPPER PROBE, PINCH TUBING, AND ALL ELECTRODES. PERFORMANCE TESTS PERFORMED WHICH WERE 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