Events

Safety Alert for FreeStyle Libre Flash Glucose 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
    2014-10-14
  • Event Date Posted
    2014-10-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141014a.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 libre flash glucose monitoring system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice (fsn) concerning freestyle libre flash glucose monitoring system, manufactured by abbott diabetes care. according to the fsn, one of the safety features of the freestyle libre system is the software, which is designed to disable the sensor if it identifies a possible loss of sensor power. in rare cases this disabling feature may not function correctly, and there is the potential for power loss to occur which may not be properly identified by the system. in these instances, when a scan is completed the sensor may provide previously collected glucose values as if they are current results. if this occurs, the results produced from the scan and seen on the reader screen may be erroneous. however, the built-in blood glucose meter system is unaffected by this issue. the above issue can be easily identified as the user would see the same glucose result on the screen each time they scanned during a period of power loss. they may also notice a gap in results on the 8-hour graph on the reader screen. if any reading from a scan seems unexpected or does not seem to match the way users are feeling, users should use the meter and test strips to perform a blood glucose test to verify the results produced by a scan. if the problem continues, users should contact abbott diabetes care customer service. furthermore, the manufacturer has made a change to the software that has corrected this issue for all newly manufactured freestyle libre sensors. for details, please refer to mhra website : http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con462307 according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 october 2014.

Device

FreeStyle Libre Flash Glucose Monitoring System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Diabetes Care FreeStyle Libre Flash Glucose 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