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 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
    2011-11-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20111102.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
    Press release
  • Reason
    Safety alert over abbott's freestyle insulinx blood glucose monitoring system today (november 2), the department of health (dh) draws public's attention to abbott diabetes care 's recall of its freestyle insulinx blood glucose monitoring system (the system) in the united kingdom, as software error in certain lots may lead to resetting of the system, including recommending the use of "0" unit of insulin even if the blood glucose readings are high, thereby having the potential of causing users to mismanage their diabetes mellitus. a dh spokesman reveals the department comes to know of the incident through its routine surveillance scheme on medical device. the system is meant to be used by diabetic patients for self-monitoring of their blood glucose status and is a device which can also offer suggestions on insulin doses required. according to the report filed by abbott to the uk authority, the defect is detected by its ongoing internal quality process. when the "backup" and "restore" functions of the freestyle auto-assist software inside the system are used for the first time, certain settings in the system may be reset. "besides the insulin calculator values, affected ones can include sound preferences, notes, reminders and weekly messages. neither is the blood glucose reading displayed nor the data stored involved," the spokesman quotes. abbott's investigation points that the defect is limited to certain lots and serial number of systems of a specific part number, with details as follows - part number lot number description potentially affected meter serial number range 71148 - 70 01r139f 01r146f 02r145f 02r153f 03r153f freestyle insulinx blood glucose monitoring system all serial numbers where the beginning seven(7) characters fall within the range: jamr128 – jamr252 preliminary enquiry with the local supplier, abbott laboratories limited, reveals that the concerned freestyle insulinx system is mainly distributed in europe and has not been launched in hong kong. "although the system is not marketed in hong kong and we have no record of related adverse event here or overseas, the fact that there may be occasional patients in the territory who have somehow obtained the devices from abroad and the dreaded consequences together justify a public alert, in our opinion," the spokesman remarks. “people who have devices belonging to the failed lots should contact abbott laboratories limited for advice and follow-up,” the spokesman urges. the company has set up a hotline at phone 2806 4488 to answer related enquiries. meanwhile, dh has informed all public and private hospitals, related medical associations and healthcare professionals about the matter and also advised them to stay vigilant. the spokesman further reminds that for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their healthcare professionals for advice as soon as possible. ends/wednesday, november 2, 2011.

Device

FreeStyle InsuLinx Blood Glucose Monitoring System
  • Model / Serial
  • Product Description
    Press release: Safety alert over Abbott's FreeStyle InsuLinx Blood 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