The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a medical device safety alert concerning Animas Insulin Pump manufactured by Animas Corporation.
According to Animas, some patients experienced gradual wear of their insulin pump keypad that led to damage, such as tearing or peeling of the edge of the keypad from the pump. Therefore, Animas has improved the durability of the insulin pump keypad, which includes the OK button, Up Arrow/ Down Arrow buttons, and the Contrast button.
The manufacturer advised all Animas Insulin Pump users to examine their insulin pump keypad for wear or damage on a regular basis, as part of the routine process of pump inspection. Animas provides a warranty for a period of four years from the date of purchase in most cases. If a customer has a confirmed issue related to the keypad and he/she is covered by the Animas warranty, Animas will replace the pump at no charge.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 July 2012