Return to the home page of DisforDiabetes

Advertisement

 







 

Press Release

FDA Safety Information: 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”
  • “Occlusion”
  • “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.htm
  • Download form 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 Notice - FDA]

Page Last Updated: 04/05/2013

        go to the top of this page
Advertisement

From the FDA
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm346788.htm

Animas Corporation's letter to users (dated January 3, 2013) is available at ImportantInformation about yourAnimas® 2020 Insulin Pump


More Press Releases

This page was new at D-is-for-Diabetes on April 8, 2013

go to the top of this page go to home page read about us contact us read our disclaimer read our privacy policy search our website go to the site map find out what's new