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You can listen anytime and anywhere. The Juicebox Podcast is available online, in your favorite podcast app, and on iTunes. Best of all you decide when to listen. While doing the laundry, grocery shopping, in the car or while you are waiting out that stubborn BG at 3 a.m. The show features conversations about day to day management, interviews with D-parents, D-Celebs and much more. Check out the reviews on iTunes and try an episode today.
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“I am the parent of a newly diagnosed 2 year old girl and I love hearing your calm and rational point of view to treating diabetes. Very refreshing and informative! Thank you.”
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.
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.