Events

Safety Alert for Freestyle Optium Neo Blood Glucose and Ketone Monitoring System

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

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
    2015-08-24
  • Event Date Posted
    2015-08-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150824.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: freestyle optium neo blood glucose and ketone monitoring system it has come to our attention that medical device manufacturer, abbott diabetes care, has issued a field safety notice concerning a glucose and ketone monitoring system - freestyle optium neo blood glucose and ketone monitoring system. the manufacturer has become aware that a basal insulin titration feature of the affected product, which provides users with a long acting insulin dose suggestion, may in error recommend “0” units of insulin to be taken. this issue is encountered when the feature has been activated by healthcare professional (hcp), while the patient is in glycaemic control and their average fasting blood glucose level is within the target range that the hcp has set. the meter should suggest the basal dose that the patient took the prior day, but instead is incorrectly recommending “0” units. therefore, the manufacturer advises the users not to use this affected feature, if activated. according to the manufacturer, the issue would not pose a significant risk to user’s health or safety. the users may continue to test their blood glucose and/or ketones as this issue does not impact blood glucose and/or ketone results received from the meter. as a permanent solution, the manufacturer will update the firmware of the product. according to the local supplier, the affected product is distributed in hong kong; nonetheless, only those units with activated basal insulin titration feature would be involved. if you are in possession of the affected products and currently using the long acting suggestion, please contact your supplier and hcp for necessary actions. posted on 24 august 2015.

Device

Freestyle Optium Neo Blood Glucose and Ketone Monitoring System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Freestyle Optium Neo Blood Glucose and Ketone Monitoring System
  • Manufacturer
    Abbott Diabetes Care

Manufacturer

Abbott Diabetes Care
  • 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