BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1180816 · Received September 23, 2008

    Report

    Report Number
    1823260-2008-07106
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    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 RECEIVED LOW SODIUM RESULTS FOR EIGHT PATIENT SAMPLES. ALL RESULTS ARE IN MMOL/L. INITIAL RESULT 130, REPEAT 135 AND 137. INITIAL RESULTS WERE NOT REPORTED FOR SAMPLE 1. INITIAL RESULTS WERE REPORTED FOR SAMPLES 2 THROUGH 8 AND HAD TO BE CORRECTED. NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE ISE REAGENT AND LOW CELL WSH DISPENSE TO NOZZLE #4. THE REAGENTS AND SOLENOID VALVE WERE REPLACED. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 2

    USER RECEIVED LOW SODIUM RESULTS FOR EIGHT PATIENT SAMPLES. ALL RESULTS ARE IN MMOL/L. INITIAL RESULT 134, REPEAT 141. INITIAL RESULTS WERE NOT REPORTED FOR SAMPLE 1. INITIAL RESULTS WERE REPORTED FOR SAMPLES 2 THROUGH 8 AND HAD TO BE CORRECTED. NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE ISE REAGENT AND LOW CELL WSH DISPENSE TO NOZZLE #4. THE REAGENTS AND SOLENOID VALVE WERE REPLACED. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 3

    USER RECEIVED LOW SODIUM RESULTS FOR EIGHT PATIENT SAMPLES. ALL RESULTS ARE IN MMOL/L. INITIAL RESULT 130, REPEAT 137. INITIAL RESULTS WERE NOT REPORTED FOR SAMPLE 1. INITIAL RESULTS WERE REPORTED FOR SAMPLES 2 THROUGH 8 AND HAD TO BE CORRECTED. NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE ISE REAGENT AND LOW CELL WSH DISPENSE TO NOZZLE #4. THE REAGENTS AND SOLENOID VALVE WERE REPLACED. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 4

    USER RECEIVED LOW SODIUM RESULTS FOR EIGHT PATIENT SAMPLES. ALL RESULTS ARE IN MMOL/L. INITIAL RESULT 126, REPEAT 135. INITIAL RESULTS WERE NOT REPORTED FOR SAMPLE 1. INITIAL RESULTS WERE REPORTED FOR SAMPLES 2 THROUGH 8 AND HAD TO BE CORRECTED. NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE ISE REAGENT AND LOW CELL WSH DISPENSE TO NOZZLE #4. THE REAGENTS AND SOLENOID VALVE WERE REPLACED. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 5

    USER RECEIVED LOW SODIUM RESULTS FOR EIGHT PATIENT SAMPLES. ALL RESULTS ARE IN MMOL/L. INITIAL RESULT 131, REPEAT 137. INITIAL RESULTS WERE NOT REPORTED FOR SAMPLE 1. INITIAL RESULTS WERE REPORTED FOR SAMPLES 2 THROUGH 8 AND HAD TO BE CORRECTED. NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE ISE REAGENT AND LOW CELL WSH DISPENSE TO NOZZLE #4. THE REAGENTS AND SOLENOID VALVE WERE REPLACED. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 6

    USER RECEIVED LOW SODIUM RESULTS FOR EIGHT PATIENT SAMPLES. ALL RESULTS ARE IN MMOL/L. INITIAL RESULT 130, REPEAT 139. INITIAL RESULTS WERE NOT REPORTED FOR SAMPLE 1. INITIAL RESULTS WERE REPORTED FOR SAMPLES 2 THROUGH 8 AND HAD TO BE CORRECTED. NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE ISE REAGENT AND LOW CELL WSH DISPENSE TO NOZZLE #4. THE REAGENTS AND SOLENOID VALVE WERE REPLACED. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 7

    USER RECEIVED LOW SODIUM RESULTS FOR EIGHT PATIENT SAMPLES. ALL RESULTS ARE IN MMOL/L. INITIAL RESULT 134, REPEAT 141. INITIAL RESULTS WERE NOT REPORTED FOR SAMPLE 1. INITIAL RESULTS WERE REPORTED FOR SAMPLES 2 THROUGH 8 AND HAD TO BE CORRECTED. NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE ISE REAGENT AND LOW CELL WSH DISPENSE TO NOZZLE #4. THE REAGENTS AND SOLENOID VALVE WERE REPLACED. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 8

    USER RECEIVED LOW SODIUM RESULTS FOR EIGHT PATIENT SAMPLES. ALL RESULTS ARE IN MMOL/L. INITIAL RESULT 131, REPEAT 140. INITIAL RESULTS WERE NOT REPORTED FOR SAMPLE 1. INITIAL RESULTS WERE REPORTED FOR SAMPLES 2 THROUGH 8 AND HAD TO BE CORRECTED. NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE ISE REAGENT AND LOW CELL WSH DISPENSE TO NOZZLE #4. THE REAGENTS AND SOLENOID VALVE WERE REPLACED. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR
    2 90 YR
    3 90 YR
    4 79 YR
    5 87 YR
    6 75 YR
    7 34 YR
    8 85 YR