Device Removal

Device Removal

FreeStyle CoPilot® Health Management System

(Part Number DOC04549-001)

FreeStyle CoPilot® Web Based Data Management System

(Part Number PRT00603-001, RevA)

August 31, 2005

Dear FreeStyle CoPilot Customer,

This communication contains information regarding FreeStyle CoPilot data management systems and is being sent to all registered users. Your attention to this information is required. Please note that the following information does not affect the performance of the FreeStyle® , FreeStyle Flash® or Precision® blood glucose monitoring systems or test strips or the Deltec Cozmo® Insulin Pump or CozMonitor® .

BACKGROUND

Abbott Diabetes Care has been monitoring the use of and customer feedback on FreeStyle CoPilot data management systems. As a result, we have identified software issues and potential report interpretation problems.

For all FreeStyle CoPilot Health Management System Users:

Modal Day Cursor Hover feature displays incorrect date and time for an individual glucose reading when the patient has adjusted the Time of Day periods to move/reclassify the reading in the Sleep period.

The use of asterisks in the Logbook Report to indicate to the viewer that there are additional glucose, carbohydrate or insulin data points available — but not presented on this specific report — may be inconsistent or unclear. The current display convention for the Logbook Report is to display the first glucose reading in a time period with an asterisk; display the sum of all carbohydrates in a time period and display the first insulin dose in a time period with an asterisk.

 For Deltec Cozmo Insulin Pump Users:

Deltec Cozmo Insulin Pump Users may see an Insulin Statistics Report (instead of the intended Pump Statistics Report). The Insulin Statistics Report includes incomplete hourly basal rate values and incorrect Average/Day Total Basal and Average/Day Total Insulin for the day of the most recent pump upload.

For all FreeStyle CoPilot Web-based Data Management Users:

On certain Reports, only one glucose value will be displayed for a defined Time Period although multiple glucose readings may exist.

Abbott Diabetes Care is committed to delivering high-quality data management solutions. Therefore, we have decided to suspend the availability of FreeStyle CoPilot data management systems in order to investigate and resolve the software problems.

 

NECESSARY ACTIONS

Effective August 31, 2005:

• FreeStyle CoPilot Web-based Data Management access will be suspended
  • FreeStyle CoPilot Health Management System will no longer be available for download through the abbottdiabetescare.com web site
  • Patients and Health Care Professionals will no longer be able to share data through the Abbott Diabetes Care Secure Internet Host

• You should discontinue use of FreeStyle CoPilot data management systems

Should you have questions or require information on obtaining alternative software, please contact Abbott Diabetes Care Customer Support at 800-553-4105 or via email at copilothelp@abbott.com. Please accept our apologies for any inconvenience this may cause.

DOC08845-Rev-A 12/06