Events

Field Safety Notices about FreeStyle Lite® Test Strips

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Abbott Diabetes Care.

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
    Field Safety Notice
  • Event Number
    SN2013(14)
  • Date
    2013-12-04
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/freestyle-lite-test-strips&id=8496f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    The irish medicines board (imb) has been notified that certain lots (lot numbers 1284962 and 1372611) of freestyle lite® blood glucose test strips may give erroneously low blood glucose results and may produce out of range control solution results when using freestyle® blood glucose meters, freestyle mini® blood glucose meters and the freestyle® meter built into the omnipod® system.
  • Action
    Advice for End Users / Patients:  1. Identify any test strips from the affected lots.  2. Follow the manufacturer’s instructions outlined in the attached field safety notices (FSNs).  3. Discontinue use and dispose of test strips from the affected lots and contact Abbott Diabetes Care Customer Service on 008000 2255 232 or 1800 776633 for a replacement of the affected test strips.  4. Ensure that you can continue to appropriately monitor your blood glucose via test strips from a different lot number or by other means. This should be done in consultation with your healthcare professional.  • Pay special attention to signs and symptoms of high blood sugar (hyperglycemia).  • Symptoms of high blood sugar may include: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.  Advice for Healthcare Professionals / Pharmacists / Distributors:  1. Identify any test strips from the affected lots.  2. Follow the manufacturer’s instructions outlined in the attached field safety notices (FSNs).  3. Discontinue use and dispose of test strips from the affected lots and contact Abbott Diabetes Care Customer Service on 1800 776633 for a replacement of the affected test strips.  4. Ensure that the appropriate personnel are made aware of this notice and the attached field safety notices. Please also pass this notice and the attached FSNs on to any end user or organisation where the potentially affected test strips have been transferred.  5. Ensure that end users who dispose of blood glucose test strips from the affected lots can continue to appropriately monitor their blood glucose.

Device

FreeStyle Lite® Test Strips

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
    HPRA