Events

Safety Alert Or Field Safety Notices for Animas IR1200, Animas IR1250 and Animas 2020

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Animas.

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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/003
  • Event Number
    CON226927
  • Date
    2013-01-22
  • Event Date Posted
    2013-01-22
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON226927?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    The pumps will only operate until 31 december 2015 due to a software problem. from 1 january 2016 the pumps will not deliver insulin and will generate a call service alarm. the manufacturer has stated that this software issue will not affect pumps prior to 1 january 2016. further information is available in the manufacturer’s field safety notice (fsn) dated 12 november 2012.
  • Action
    Identify affected devices. Ensure that staff and patients who are affected are aware of this problem. Contact the manufacturer to arrange for replacement pumps.  Please note that they will only be providing free-of-charge replacements for pumps that are within warranty. Ensure that all affected pumps are replaced before 31 December 2015. Diabetes departments Pharmacists Those involved in the procurement, supply and use of this device.

Device

Animas IR1200, Animas IR1250 and Animas 2020
  • Model / Serial
  • Product Description
    Ambulatory insulin infusion pumps. Animas IR1200, Animas IR1250 and Animas 2020. All serial numbers . Animas no longer distributes the IR1200, IR1250 or the 2020 models in the UK. Affected pumps will be replaced with a different model of Animas insulin infusion pump. Animas will be providing training on the use of the replacement pumps. The manufacturer considers pumps that are outside the warranty period to have exceeded their expected life, and so will only be providing free-of-charge replacements for pumps that are still within warranty on 31 December 2015. Please note that all IR1200 and IR1250 pumps will be out of warranty by 31 December 2015.
  • Manufacturer
    Animas

Manufacturer

Animas