||December 03, 2009
||Animas ezManager Max Diabetes Management System version 2.0.9
200 Lawrence Dr
West Chester, Pennsylvania 19380-3428
|For Additional Information Contact
|Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
||Animas issued an Urgent Medical Device Correction letter dated 11/2/09 to the pump user and another letter to the health care professional that prescribed the pump. The letters explain the issue. The patient letter is accompanied with a CD that contains the upgraded software and instructions to follow.
|Quantity in Commerce
||Nationwide distribution, and Canada, Cayman Islands, and Denmark.