Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom has posted a field safety notice concerning Animas 2020, Animas IR 1200 and Animas IR 1250 Infusion Pumps manufactured by Animas Corporation.

The manufacturer informed the affected users that the software included in these three (Animas 2020, IR1250 and IR1200) pump models only operates until midnight on Dec. 31, 2015. After this date, these pump models will no longer deliver insulin and will generate Call Service Alarms. This end of use date is not currently included in the product labeling.

According to the manufacturer, this software issue will not affect the pumps' operation prior to January 1, 2016. There is no immediate health risk, and patients using these pump models do not need to take any action at this time.

For Animas 2020 pump users whose pumps will still be in warranty as of December 31, 2015:-

• Prior to the end of 2015, free replacement pumps to pump users will be provided for those who are still in-warranty to ensure their care with pump therapy is not interrupted.

For patients whose pumps are no longer in warranty as of December 31, 2015:-

• Between now and the end of 2015, the manufacturer will be proactively reaching out to all out-of-warranty Animas 2020, Animas IR1250 and Animas IR1200 to remind them of this issue and to ensure their transition to a newer pump model.

For details, please refer to the MHRA website:
http://www.mhra.gov.uk/Safetyinformation/ Safetywarningsalertsandrecalls/fieldsafetynotices/CON205360

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 20 November 2012