On March 28, 2012, Smiths Medical announced that it is initiating a U.S. and Canada, voluntary market withdrawal of CoZmonitor Blood Glucose Monitoring Systems. Smiths Medical is conducting this voluntary market withdrawal because the test strips used with the CoZmonitor are no longer available and no alternative test strips are compatible with the CoZmonitor. Customers using the CoZmonitor should seek an alternative Blood Glucose Meter.
Announced June 5, 2004, the CoZmonitor blood glucose module has received FDA clearance. The CoZmonitor blood glucose module is attached to the back of the Deltec Cozmo insulin pump to create an all-in-one insulin pump and blood glucose monitoring system. The Deltec Cozmo insulin pump keypad and screen are used for all blood glucose testing functions and results.
Smiths Medical MD partnered with Abbott Diabetes Care to create the CoZmonitor blood glucose module, which utilizes FreeStyle Flash technology and readily available FreeStyle test strips. "It was very important for us to partner with a company like Abbott Diabetes Care so we could utilize their proven blood glucose monitoring and test strip technology rather than creating something completely new," said Rod Kellogg, Vice President and General Manager of the Diabetes Division of Smiths Medical MD.
To support FDA clearance, a CoZmonitor blood glucose module usability study was conducted with 57 children and adults. All 57 participants were able to successfully use the CoZmonitor blood glucose module without any additional training. "The CoZmonitor blood glucose module is a major advancement in making diabetes management easier," said Dr. Howard Wolpert, Director, Insulin Pump Program, Joslin Diabetes Center. "Blood glucose monitoring is essential for good diabetes management. By attaching the CoZmonitor blood glucose module to the back of the Deltec Cozmo insulin pump, patients will never have to worry about where their blood glucose monitor is."
Smiths Medical MD (Medication Delivery) designs, manufactures, and distributes medical devices used in infusion therapy, including ambulatory infusion pumps, large volume infusion pumps, implantable access systems, dialysis and infusion catheters, needles, and insulin delivery systems.