BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1162206 · Received September 16, 2008

    Report

    Report Number
    1823260-2008-06922
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING LOW RESULTS FOR SODIUM FOR APPROXIMATELY 150 PATIENT SAMPLES. SIX EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT 133 MMOL/L, REPEAT 139 MMOL/L. SAMPLE 2 INITIAL RESULT 134 MMOL/L, REPEAT 141 MMOL/L. SAMPLE 3 INITIAL RESULT 130 MMOL/L, REPEAT 137 MMOL/L. SAMPLE 4 INITIAL RESULT 121 MMOL/L, REPEAT 130 MMOL/L. SAMPLE 5 INITIAL RESULT 135 MMOL/L, REPEAT 141 MMOL/L. SAMPLE 6 INITIAL RESULT 132 MMOL/L, REPEAT 139 MMOL/L. INITIAL RESULTS WERE REPORTED. USER STATES HE IS NOT SURE IF ANY PATIENTS HAD BEEN TREATED BASED ON THESE RESULTS. USER DID NOT REPORT ANY ADVERSE EVENTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE ISE SIPPER PROBE WAS HITTING THE SIDE OF THE ISE BATH AND ADJUSTED THE SIPPER PROBE. PERFORMANCE TESTS WERE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK