Events

Safety Alert Or Field Safety Notices for FreeStyle InsuLinx

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by manufacturer #17429.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/025
  • Event Number
    CON267923
  • Date
    2013-05-01
  • Event Date Posted
    2013-05-01
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON267923?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    At extremely high blood glucose levels of 56.8 mmol/l and above, the meter will display and store in its memory an incorrect low test result. an incorrect low result may delay a diagnosis of diabetic ketoacidosis and suggest an incorrect insulin dose. the manufacturer has published a field safety notice on this problem dated 15 april 2013. there are no other abbott diabetes care products affected by this issue. the performance of the test strips is not affected by this problem. the meter is capable of reporting results in the range 1.11 to 27.78 mmol/l. a communication has been sent out by the manufacturer to customers, healthcare professionals and pharmacists detailing the issue.
  • Action
    Healthcare professionals to immediately discontinue supplying these meters and return any unused meters to your supplier. Healthcare professionals and pharmacists to advise users to either:     download new software through the Auto-Assist computer application supplied with the meter or     obtain a replacement meter by contacting Abbott Diabetes Care Customer Service (0800-088-5521). Pharmacists supplying FreeStyle Lite blood glucose test strips advise users with FreeStyle InsuLinx meters to either:     upgrade their meters by downloading and installing new meter software through the Auto-Assist personal     computer application supplied with the meter. When connected, users will be prompted to upgrade where     required. A link to the website www.freestyleinsulinx.com/swupdate is provided in the communication to     customers, healthcare professionals and pharmacists     or     contact Abbott Diabetes Care Customer Service to obtain a replacement meter (0800-088-5521).     Meters with the updated software are marked with a yellow circle on the carton near the lot number. Healthcare professionals who manage patients who use FreeStyle InsuLinx meters: Identify patients who are using these meters. If you have FreeStyle InsuLinx meters in your current stock contact Abbott Diabetes Care customer care for replacements. Advise users of FreeStyle InsuLinx meters to either: upgrade their meters by downloading and installing new meter software through the Auto-Assist personal computer application supplied with the meter. When connected, users will be prompted to upgrade where required. A link to the website www.freestyleinsulinx.com/swupdate is provided in the communication to customers, healthcare professionals and pharmacists           or           contact Abbott Diabetes Care Customer Service to obtain a replacement meter (0800-088-5521).   Meters with the updated software are marked with a yellow circle on the carton near the lot number. Healthcare professionals who manage patients who use this device. Pharmacists supplying FreeStyle Lite blood glucose test strips.

Device

FreeStyle InsuLinx

Manufacturer

manufacturer #17429