Animas Insulin Pump Recall: Battery Caps Used With Pump May Fail

The FDA has posted notice of a battery cap recall for Animas Insulin Pumps featuring the OneTouch Ping System. The battery caps, which were manufactured since June 1, 2008, may lose contact with the battery compartment of the pump, potentially causing the insulin pump to reset or fail.

The batter caps were used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump and Animas IR1250 Insulin Pump.

Animas Corporation, which is a subsidiary of Johnson & Johnson, has sent letters by certified mail to patients notifying them about the defective batter caps which may cause the Animas Insulin Pump to inadvertently shut down. Replacement battery caps were included with the letter, and users were advised to immediately replace the defective battery caps.

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The Animas Insulin Pumps are used to administer insulin in the treatment of diabetes mellitus, as an alternative to daily injrections of insulin by syringe or an insulin pen.

Due to the Animas battery problems, there could be an intermittent loss of contact between the battery cap and the battery compartment, which could cause the device to reset. This could interrupt the delivery of insulin or cause users to believe more insulin was delivered than they actually received, contributing to errors in future doses.

Interruption of the Animas Insulin Pump could result in excess levels of glucose in the blood (hyperglycemia) and confusion about the amount of insulin delivered could result in lower than normal levels of glucose in the blood (hypoglycemia).

The FDA has notified healthcare providers about this recall to ensure that all of their patients with a OneTouch Ping System, Animas Insulin Pump replace their battery caps. In addition, Animas Corporation is continuing their attempts to contact any patients who have not acknowledged that they received the recall notice.

The FDA has classified the Animas recall as a Class I recall since failure to change the Animas Insulin Pump battery cap could result pose a serious risk of injury to diabetics who rely on the devices. Additional information can be obtained directly from Animas at (866) 423-4087.


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