BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1191558 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07210
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING DISCREPANT RESULT FOR SODIUM. TOTAL NUMBER OF PATIENT SAMPLES AFFECTED IS UNKNOWN. FIVE EXAMPLES WERE PROVIDED. SAMPLE 1, INITIAL RESULT 132 MMOL/L, REPEAT 139 MMOL/L. INITIAL RESULTS WERE REPORTED AS THEY WERE ALERTED TO THE ISSUE BY THE DOCTOR QUESTIONING THE RESULTS. USER STATES SHE DOES NOT THINK ANY PATIENTS WERE TREATED BASED ON THE ERRONEOUS RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS POSSIBLE CONTAMINATION AND PERFORMED DECONTAMINATION. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 2

    USER RECEIVING DISCREPANT RESULT FOR SODIUM. TOTAL NUMBER OF PATIENT SAMPLES AFFECTED IS UNKNOWN. FIVE EXAMPLES WERE PROVIDED. SAMPLE 2, INITIAL RESULT 132 MMOL/L, REPEAT 139 MMOL/L. INITIAL RESULTS WERE REPORTED AS THEY WERE ALERTED TO THE ISSUE BY THE DOCTOR QUESTIONING THE RESULTS. USER STATES SHE DOES NOT THINK ANY PATIENTS WERE TREATED BASED ON THE ERRONEOUS RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS POSSIBLE CONTAMINATION AND PERFORMED DECONTAMINATION. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 3

    USER RECEIVING DISCREPANT RESULT FOR SODIUM. TOTAL NUMBER OF PATIENT SAMPLES AFFECTED IS UNKNOWN. FIVE EXAMPLES WERE PROVIDED. SAMPLE 3, INITIAL RESULT 128 MMOL/L, REPEAT 134 MMOL/L. INITIAL RESULTS WERE REPORTED AS THEY WERE ALERTED TO THE ISSUE BY THE DOCTOR QUESTIONING THE RESULTS. USER STATES SHE DOES NOT THINK ANY PATIENTS WERE TREATED BASED ON THE ERRONEOUS RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS POSSIBLE CONTAMINATION AND PERFORMED DECONTAMINATION. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 4

    USER RECEIVING DISCREPANT RESULT FOR SODIUM. TOTAL NUMBER OF PATIENT SAMPLES AFFECTED IS UNKNOWN. FIVE EXAMPLES WERE PROVIDED. SAMPLE 4, INITIAL RESULT 134 MMOL/L, REPEAT 141 MMOL/L. INITIAL RESULTS WERE REPORTED AS THEY WERE ALERTED TO THE ISSUE BY THE DOCTOR QUESTIONING THE RESULTS. USER STATES SHE DOES NOT THINK ANY PATIENTS WERE TREATED BASED ON THE ERRONEOUS RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS POSSIBLE CONTAMINATION, AND PERFORMED DECONTAMINATION. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 5

    USER RECEIVING DISCREPANT RESULT FOR SODIUM. TOTAL NUMBER OF PATIENT SAMPLES AFFECTED IS UNKNOWN. FIVE EXAMPLES WERE PROVIDED. SAMPLE 5, INITIAL RESULT 130 MMOL/L, REPEAT 136 MMOL/L. INITIAL RESULTS WERE REPORTED AS THEY WERE ALERTED TO THE ISSUE BY THE DOCTOR QUESTIONING THE RESULTS. USER STATES SHE DOES NOT THINK ANY PATIENTS WERE TREATED BASED ON THE ERRONEOUS RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS POSSIBLE CONTAMINATION AND PERFORMED DECONTAMINATION. PERFORMANCE TESTS WERE PERFORMED.

    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 63 YR
    2 56 YR
    3 39 YR
    4 61 YR
    5 45 YR