Summary Safety Review - Omnipod Insulin Management System - Assessing the potential risk of malfunctions with the device

March 21, 2018

Product

Omnipod Insulin Management System

Potential Safety Issue

Malfunctions with the device

Key Messages

• The Omnipod Insulin Management System (Omnipod) is licensed for sale in Canada to manage blood sugar levels in people with diabetes who need insulin.
• Health Canada reviewed the risk of malfunctions with the Omnipod because of an increase in the number of complaints in the last 3 years, as part of active monitoring of the device. Some of the complaints reported serious consequences to patients such as high or low level of blood sugar resulting in hospitalisations.
• Health Canada's review concluded that there is no new safety risk for the Omnipod. Health Canada will continue to monitor the safety of the Omnipod.

Overview

In 2014, Health Canada completed a first safety review for the Omnipod because a high number of complaints, reporting high level of blood sugar (hyperglycemia), were received at the time of the review. The review did not find a need for additional safety measures and recommended to actively monitor issues with the Omnipod.

As part of the recommended active monitoring of the Omnipod, Health Canada saw an increase in the number of complaints in the last 3 years about device malfunctions. As a result, Health Canada started another safety review that included an assessment of detailed information provided by the manufacturer and all new complaints reported since the 2014 safety review.

Use in Canada

• The Omnipod is a medical device licensed for sale in Canada since 2009 to manage blood sugar levels in people with diabetes who need insulin. It delivers insulin for up to 3 days.
• The Omnipod contains 2 parts:
  • a Pod, which is a single-use disposable device, filled with insulin and placed directly on the body to deliver insulin; and
  • a Personal Diabetes Manager (PDM), which is a remote controller that manages insulin delivery from the Pod and includes a sugar (glucose) meter.

Safety Review Findings

• At the time of the 2017 review, Health Canada had received a total of 1806 complaints associated with the Pod and 28 with the PDM since the licensing of the device. Annual numbers of complaints for the Omnipod increased in the last 3 years, from 154 reported in 2015, 550 in 2016 and 706 from January to November 2017. The following patient outcomes were described in the incidents reported since the last review (more than 1 outcome can apply to 1 complaint report): 98 hospitalizations, 58 cases of high levels of acids (ketones) in the blood/urine with low blood pH (diabetic ketoacidosis), 824 cases of high levels of sugar in the blood (hyperglycemia), 19 cases of low levels of sugar in the blood (hypoglycemia), 41 cases of skin irritation, and 1 death. At this time, there is not enough information to conclude that these outcomes were linked to the malfunctions of the Omnipod. In 215 complaints, no consequences to the patient were reported.
• According to the manufacturer's analysis, the complaint rates for device malfunction (key modes of failure) have increased, but are still considered low. These malfunctions include pod error or hazard alarm during operation, occlusion alarm (to warn the patient of a potential insulin delivery issue), skin irritation and adhesive problems, needle mechanism failure, and patients being unsure if the pod is delivering insulin.
• As a result of the analysis of the causes of malfunctions and any actions taken, the manufacturer explained that Pod errors and alarms are safety measures to make sure that any risks of incorrect insulin delivery are corrected quickly. This helps to make sure that the user's blood sugar level does not get too high or too low. The manufacturer also discussed some design changes that are ongoing to reduce potential malfunctions with the device.
• In addition, the review of the available information concluded that the increase in the number of complaints seen seemed to be related to a higher number of sales of the Omnipod.

Conclusions and Actions

• Health Canada's review concluded that there is no new safety risk for the Omnipod. The safety information for this medical device is appropriate at this time.
• Health Canada encourages users and healthcare professionals to report any side effects related to the use of the Omnipod.
• Health Canada will continue to monitor safety information involving the Omnipod, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information and what is known about the use of this medical device both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.