Events

Field Safety Notices about Animas Insulin Pump (IR 1200, 2020, One Touch Ping, Vibe)

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Animas Corporation.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2012(14)
  • Date
    2012-08-28
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/animas-insulin-pump-(ir-1200-2020-one-touch-ping-vibe)&id=ad7df825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    There is a risk of compromised insulin delivery whereby keypad buttons become unresponsive. the issue can arise due to wear and tear of keypads on the insulin pump, or sticking of keypad buttons.
  • Action
    1. Ensure that all pump users are aware of the information provided in the attached  Field Safety Notice (FSN) issued recently by Animas.  2. Pump users experiencing problems with their device or experiencing keypad issues are encouraged to contact Animas without delay to arrange for a  replacement as outlined in the FSN.  3. Pump users are encouraged to report any issues with pump keypad both to Animas and to the IMB using the contact details provided below.

Device

Animas Insulin Pump (IR 1200, 2020, One Touch Ping, Vibe)
  • Model / Serial
  • Product Description
    Animas Insulin Pump (IR 1200, 2020, One Touch Ping, Vibe)
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation