Events

Safety Alert for FreeStyle InsuLinx Blood Glucose Monitoring System

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

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
    2013-04-16
  • Event Date Posted
    2013-04-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130416c.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: abbott diabetes care freestyle insulinx blood glucose monitoring system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning freestyle insulinx blood glucose monitoring system, manufactured by abbott. abbott has determined that at extremely high blood glucose levels of 56.8 mmol/l and above, the freestyle insulinx meter will display and store in memory an incorrect test result that is 56.8 mmol/l below the measured result. for example, a blood glucose value of 59.1 mmol/l will be displayed and stored as a value of 2.3 mmol/l (59.1 mmol/l–56.8 mmol/l = 2.3 mmol/l). if the freestyle insulinx meter displays an inaccurate low result, there may be a delay in identification and treatment of severe hyperglycemia, or incorrect treatment may be given. product recall and replacement is on-going from distributors and health care providers. the affected patients are advised to update the software on the affected meters immediately, or they can contact their local abbott diabetes care customer service for assistance. according to the local supplier, abbott diabetes care, the affected product has not been distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con261768 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2013.

Device

FreeStyle InsuLinx Blood Glucose Monitoring System

Manufacturer

Abbott
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH