OmniPod Needle Mechanism May Fail to Deploy
The post title has been edited to remove the phrase "voluntary recall" because I mistakenly used the phrase. This is not a recall, voluntary or otherwise - it is a Field Safety Notification. My apologies to all. - Best, Scott
from Insulet
Insulet Corporation
November 2, 2015
URGENT: Field Safety Notification
OmniPod® Insulin Management System
Certain OmniPod Lots Specified Below
Dear Valued Insulet Customer,
Insulet Corporation, the manufacturer of the OmniPod Insulin Delivery System, is committed to keeping you and your healthcare professionals up-to-date in the event there are any issues that arise related to our products.
As part of our product quality monitoring process, we have identified that 15 lots of OmniPod which were distributed in the U.S. had a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. The reported incidence of this product issue in the affected lots is approximately 1%-2%. Once we recognized this, we corrected the manufacturing process and implemented additional inspection steps.
No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.
How do I know if I have affected product?
This Field Safety Notification affects only the Pods and does not affect the OmniPod Personal Diabetes Manager (PDM). The slight increase was identified in the following lots of Pods:
The lot number is located on the Pod tray lid label, the side of the Pod and on the end of the box of Pods.
To open a PDF version of the Insulet Announcement - click
What is the risk?
In the event a needle mechanism fails to deploy, the needle will not be inserted and insulin delivery will not begin. The interruption of insulin delivery may cause elevated blood glucose (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis (DKA). If you believe you have successfully activated your Pod and you experience unexpected elevated blood glucose levels, please consult your healthcare professional.
Upon activation, how do I know if the needle mechanism deployed?
After you press the Start button on the PDM, you should hear a few soft clicks and then a louder click from the Pod indicating that the needle mechanism has deployed. If you do not hear this within a few seconds after pressing Start, the Pod has failed to deploy.
You should also feel the insertion of the needle mechanism deployment. The PDM will indicate that the Pod is active and prompt you to check to ensure the cannula is properly inserted (Figure 5-23 in my PDF). For more information, please see the User Guide.
You should always check the infusion site after insertion to ensure that the cannula was properly inserted.
When you see the pink slide insert in this position, it means that the cannula is inserted (See figure in my PDF).
The PDM will automatically remind you to check your blood glucose 1.5 hours after each Pod change. If the cannula is not properly inserted, hyperglycemia may result.
If you experience unexpected elevated blood glucose levels, change your Pod and contact your healthcare provider.You may also call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification.
This voluntary action is being taken by Insulet Corporation with the knowledge of the U.S. Food and Drug Administration (FDA). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or by fax.
We appreciate how you depend on us and sincerely regret any inconvenience this may cause you. We are focused on delivering the highest level of product quality and your complete satisfaction is our top priority.
Sincerely,
Michael Spears
Vice President, Quality, Regulatory & Clinical Affairs
Insulet Corporation
Announcement can be found on the Insulet website with this link.
JDRF T1D Looks Like Me Campaign
November is Diabetes Awareness Month
I want to start diabetes awareness month by highlighting a social media campaign that the JDRF is sponsoring. The JDRF is inviting people to visit http://jdrf.org/t1dlookslikeme and use their cool web based mini photoshop doohickey to shade a picture of themselves in blue. After the blue tint is applied (all of this takes just a few moments) your photo will be adorned with the "JDRF T1D Looks Like Me" logo and you are then able to download the image and or share it online with one of your social media accounts. Such an easy and wonderful way of putting a face to type 1 and type 2 diabetes. Don't forget the hashtag, #T1DLOOKSLIKEME
You Could Be a Consumer Representative on an FDA Advisory Committee
from fda.gov
By: CAPT Dornette Spell-LeSane, M.S.N., M.H.A., A.N.P.-B.C.
Have you ever wanted to be part of the food and drug regulatory process? Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data?
CAPT Dornette Spell-LeSane, M.S.N., M.H.A., A.N.P.-B.C.
[Dornette Spell-LeSane] If you answered “Yes,” here’s your opportunity to become an advocate for consumers! The Food and Drug Administration continually seeks input from consumers on scientific and medical issues by including Consumer Representatives on Agency advisory committees.
Participation as a Consumer Representative requires a modest time commitment. Travel expenses are paid and representatives receive reasonable compensation.
Consumer Representatives serve as Special Government Employees on a committee for up to a four-year term. Committees meet 1-3 times annually for 1-2 days. All meetings are held in the Washington, D.C. area. Members receive per-diem and travel expenses and are paid at a GS-15/10 hourly rate for the days attending a meeting.
Consumer Representatives provide the perspective of consumers to advisory committees and do not represent their own personal expertise. Their role is to:
Represent the consumer perspective on issues and actions before the advisory committee;
Serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and, Facilitate dialogue with the advisory committees on scientific issues that affect consumers.
if you want to learn more including how to apply... click here.
You Can Help to Create CGM Medicare Coverage
If you speak up, things will change!
I am a huge proponent of continuous glucose monitoring and believe that everyone deserves it's benefits and protection if they want it. Please take a moment to help the JDRF give a friendly push to our legislators. Doing the right thing for older people who have type 1 diabetes is the least that should be done. Your participation only takes a few moments and I've seen the JDRF's actions help issues like this in the past. If you speak up, things will change! Thank you, Scott
One Voice Calling for Medicare Coverage of Continuous Glucose Monitors (CGMs)
We need your help. Ask the U.S. Senate and U.S. House of Representatives to cosponsor bipartisan bills to ensure people over 65, and who are Medicare-eligible, have access to life-saving CGMs!
The Co-Chairs of the Senate Diabetes Caucus have reintroduced important bipartisan legislation (S. 804)
—the “Medicare CGM Access Act of 2015”—that would facilitate Medicare coverage for continuous glucose monitors (CGMs) and help pave the way for the next generation of CGM-related technologies, such as artificial pancreas (AP) systems.
This legislation now joins a bipartisan companion bill, (H.R. 1427), the “Medicare CGM Access Act of 2015,” introduced in the U.S. House by the leadership of the Congressional Diabetes Caucus.
But we still need your help! Please take a few minutes to:
- Email your Representatives and ask them to support H.R. 1427, the “Medicare CGM Access Act of 2015.”
- Email your Senators and ask that they support S. 804, the “Medicare CGM Access Act of 2015.”
After you complete these two simple action steps, please ask your friends, family, neighbors and coworkers to do the same! And spread the word on your favorite social media pages using the hashtag #MedicareCoverCGM.
Why CGMS should be covered by Medicare
CGMs are FDA-approved, physician-prescribed devices that detect and display blood-glucose levels continuously—and reveal trends in these levels that often go unnoticed. A JDRF-funded CGM trial has shown that the rate of severe high blood-sugar (hypoglycemia) events among adults using a CGM fell by two-thirds over the first year of use. Not surprisingly, CGMs are recommended by national diabetes clinical guidelines—and they’re covered by nearly all private health plans.
Unfortunately, Medicare does not currently cover CGMs—despite the evidence of clinical benefit. The result? Millions of seniors with diabetes are left vulnerable to severe low blood-sugar (hyperglycemia) events that can lead to seizures, bouts of unconsciousness and hospitalization. And the costs are not just physical:
- Hypoglycemia inpatient admission rates are an average of $17,564 per visit.
- Diabetes is one of the costliest chronic diseases, accounting for $245 billion in economic losses in 2012, including $176 billion in direct medical costs.
- Of that $176 billion, 59 percent is attributed to those ages 65 and older.
- Overall, 42 percent of Medicare fee-for-service spending is attributed to people with diabetes.
JDRF has been working closely with other interested stakeholders to encourage Medicare to cover CGM devices—and we have made it one of our top national advocacy priorities. While we continue to work to resolve this issue quickly, we need your help to build support within Congress.
Please take action today!
Remember, all you have to do is:
Never before seen Dexcom G5 images!
Dexcom has just announced that the G5 system has been approved today by the FDA and I have some exclusive images for you to check out! There are more images on the announcement page as well as information on release dates, cost and a promo video from Dexcom. Enjoy these and then check out the rest...
Just 24 hours after the surprise FDA approval of the Dexcom G5 continuous glucose monitoring system, I spoke with Dexcom EVP Steven Pacelli and asked him all of the questions about the new G5 that were submitted to me by blog readers and podcast listeners - I even threw in a few of my own. You can listen here, on iTunes or wherever fine podcasts are available.
