FDA Classifies Previous Field Action for Animas® 2020 Insulin Pump as Class I Recall

Press release from Animas

April 08, 2013

The U.S. Food and Drug Administration (FDA) has classified Animas Corporation’s January 2013 field action related to Animas® 2020 Insulin Pump as a Class I recall.

The voluntary recall, initiated on January 3, 2013, involves only a small supply of our Animas® 2020 insulin pumps manufactured between March and November 2012. Affected patients were notified in early January and were provided with a replacement pump. Animas recently discontinued the Animas® 2020 insulin pump in North America, and therefore replaced the 2020 pumps in the hands of patients with a OneTouch® Ping®Glucose Management System, which includes an insulin pump and a glucose meter that can also act as a remote controller of the pump.

Animas initiated the voluntary worldwide recall due to a component issue impacting a small supply of our Animas® 2020 insulin pumps. In certain pumps, the component issue may have resulted in triggering a pump to sound a false alarm or warning related to one of the following: “Loss of prime,” “Occlusion” or “No Cartridge detected.” Patients are not at any risk from this component issue as long as they follow the safety instructions in the Animas Owner’s Booklet and always disconnect the infusion set from the body when rewinding the motor, loading the cartridge or priming the infusion set.

Animas informed FDA about this recall in December 2012 before beginning the process of notifying patients, healthcare professionals, distributors and our partners of the recall by official letter beginning January 3, 2013. The initial letter included detailed recall instructions and was posted on our Web site athttp://www.animas.com/product-safety. Regulatory authorities worldwide also have been informed.

If healthcare professionals or patients have any additional questions about the Animas® 2020 Insulin Pump recall, they may call our Customer Technical Support Center at 8667935253.

I think we are all fond of our Animas pumps, but we should also hear the FDA's version of the story:

Animas Corporation 2020 Insulin Infusion Pump: Class I Recall - False Alarm or Warning Sound

[Posted 04/05/2013]

AUDIENCE: Risk Manager, Patient

ISSUE: Animas identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following:

“Loss of prime”
“No Cartridge detected”
If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect your infusion set from your body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia.

The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no linger deliver insulin and will generate a “Call Service Alarm.”

BACKGROUND: The Animas 2020 Insulin Pumps are used to deliver insulin directly into your blood for the treatment of diabetes.

RECOMMENDATION: Customers with the device should contact Animas’ Product Fulfillment Center at 877-280-2339 between the hours of 6 a.m. and 12 a.m. EST to schedule shipment of your free replacement pump. Customers with technical questions or who want to report a concern should contact Customer Technical Support Center at 866-793-5253.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
Download form2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/05/2013 - Recall Notice3 - FDA]