Events

Recall of FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System. An in vitro diagnostic medical device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abbott Australasia Pty Ltd T/A Abbott Diabetes Care.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00672-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00672-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Abbott has identified that the basal insulin titration feature may recommend that “0” units of insulin be taken instead of the correct insulin amount. this issue is encountered when the average fasting blood glucose level is within the target range set by your hcp. the meter should suggest the long action dose you took the prior day, but instead is recommending “0” units. if the fasting glucose is not within the set target range, the meter will recommend the correct long acting insulin dose suggestion.This issue was identified through an overseas complaint. there have been no reports of injury or mistreatment associated with this issue. currently, abbott is not aware of any patients affected by this issue in australia and have contacted all hcps trained to activate this feature. patients 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.
  • Action
    The activation code for the Basal insulin Titration feature has only been provided to 15 Health Care Professionals (HCPs). Abbott Diabetes Care is advising affected HCPs to only setup the feature on unaffected devices and is providing instructions on how to identify affected devices. This information will also be provided to any new HCPs that receive training to activate this feature. Abbott Diabetes Care has taken steps to ensure that affected HCP stock only contains the updated FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System.

Device

FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System. An in vitro diagnostic medical d...

Manufacturer

Abbott Australasia Pty Ltd T/A 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
    DHTGA