Events

Safety Alert for Animas 2020 Insulin Infusion 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
    2013-02-05
  • Event Date Posted
    2013-02-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130205.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 2020 insulin infusion pump health canada has posted a medical device safety alert concerning animas 2020 insulin infusion pump manufactured by animas corporation. the affected model/catalogue numbers are 100-380-51, 100-381-51, 100-382-51, 100-384-51, 100-385-51 respectively. a small number of animas 2020 insulin infusion pumps are potentially affected by a misalignment of a component on the printed circuit board assembly. this component misalignment results in the insulin pump potentially measuring force conditions incorrectly, resulting in false warnings and/or alarms. should the patient complete a load sequence or prime the insulin infusion pump and does not disconnect from the infusion set from the body, the insulin infusion pump may dispense all of the insulin in the cartridge into the patient. there is no safety risk as long as the patient follows the instructions for use and always disconnects the infusion set prior to priming the pump, changing the cartridge, and rewinding the motor. according to the local supplier, the affected products are not distributed in hong kong. for details, please visit the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/ rec-ret_md-im_date_jan-mar_2013-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 05 february 2013.

Device

Animas 2020 Insulin Infusion Pump
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Animas 2020 Insulin Infusion Pump
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation