FDA MedWatch

Animas Insulin Pumps: Battery Caps - Class 1 recall due to inadvertent device resetting, risk of hyperglycemia
Pump, and Animas IR1250 Insulin Pump

Audience: Consumers, endocrinological healthcare professionals

11/25/2008- Animas Corporation and FDA informed consumers and healthcare professionals of a nationwide recall of battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump. The battery caps used with the above infusion pumps were manufactured from June 1, 2008 through July 31, 2008, and were distributed from June 16, 2008 through August 1, 2008.
There may be an intermittent loss of contact between the battery cap and the battery compartment in the pump which may result in the device resetting. This can cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia). Healthcare professionals are advised to ensure that their patients replace the battery cap on their insulin pump.

Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 Recall Notice, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#batterycap