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:

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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.

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The Juicebox Podcast is free and available everywhere! iTunes, Stitcher, your favorite podcast app, here on the blog and coming soon to Google Play.

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

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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.

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Have Questions for Dexcom? Ask them here!

Your questions for Dexcom on the Juicebox Podcast...

Soon I'll be interviewing Mike Mensinger from Dexcom for my podcast. Mike is the Director of Mobile and Cloud Services Software Development at Dexcom - in short, Mike knows all about the apps and software at Dexcom and we are going to get to pick his brain, ask questions and offer suggestions.

At the moment we are in the middle of working out a time that works for us and will be recording this podcast episode either in the next few days or sometime next week. If you have something you'd like to add to the conversation don't hesitate. Leaving your thoughts as a comment on this post will help me to keep everything in one place but if you have something that you feel is private to add, feel free to email me. 

Thanks in advance for participating! I'll do my best to get everyone's questions in during the time that Mike and I have together. In the meantime you may want to listen to my podcast episodes with Dexcom's CEO Kevin Sayer and their EVP Steve Pacelli.

The Juicebox Podcast is available online, at iTunes, with Stitcher and everywhere fine podcasts are heard.

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Diabetes Support on Instagram

Jenna Feely was a recent guest on my podcast where she talked about being diagnosed at thirteen years old, her adolescences with type 1 and her outlook on her life with the disease. About halfway through the conversation I asked Jenna about her advocacy online and she told me about her Instagram page (She has nearly 5,000 followers!), later I asked her if she would write a guest post for Arden's Day about her experience with type 1 advocacy and how she uses her Instagram page to help people. I hope you enjoy her post and take time to listen to her episode, 'Eighteen and Already Amazing'! - Best, Scott

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When I am not feeling my best, I seek support.  When I am feeling positive, I try to give support.

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When I was diagnosed with type 1 diabetes, I was 13 years old and I had no idea what type 1 diabetes was.  I also didn’t know that social media could have really helped me in that moment. It took me a couple of years to realize that social media could be a huge outlet to connect with others going through the same daily monitoring to take care of themselves.

It can be easy to feel isolated when living with type 1 diabetes.

We have to take care of ourselves, and monitor our health in ways that most will never have to.  Whether you prefer Facebook, Instagram, YouTube, or other sites that provide support, you can voice your concerns, your worries, your progress, or just have a good laugh!

Jenna is in Instagram @DiabetesTips - Search in your app or click on this image to check her out and follow.

Social media has provided an outlet for me that helps me relate to others, and hopefully help others with type 1 diabetes.  I love being able to support others who may be having a tough day, and talking to others who are dealing with the same bumps that I am.  It can be very easy to feel different, or cut off from the world when you are living with a chronic disease.  However, diabetes has actually helped me in many ways that, as a society I feel we tend to ignore.  Yes, I have had sleepless nights, scary lows, scary highs…..but through all that pain I have also learned to move on, and to get on with life.  Diabetes has taught me to be more patient with others as well as myself.  I have also learned to forgive others as well as myself.  As you all probably know, if you don’t forgive yourself for those little mistakes, you will go crazy!

When you know how it feels to have a chronic illness, you can empathize with others who are also going through something similar, even if it is not type 1.

We can learn from each other through social media. 

We can all share tips, and tricks that we may have found over the years whether they relate to physical or emotional wellness in our management.  Social media also helps me stay inspired in my management.  When I am not feeling my best, I seek support.  When I am feeling positive, I try to give support.  We can all give and take from each other.  Through social media, we can help others forgive themselves, support each other through sleepless nights, and also add a little humor to type 1! 

You can find Jenna on Instagram @DiabetesTips and I am on Instagram @ArdensDay. Jenna's episode of the Juicebox Podcast can be found here, listened to below, on iTunes or where ever you get your podcast fix.

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