Events

Safety Alert for Animas Insulin Pump

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Animas Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-07-25
  • Event Date Posted
    2012-07-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120725a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: animas insulin pump 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.

Device

Animas Insulin Pump
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Animas Insulin Pump
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation