Omnipod does not work well--at least for me!

I think the FDA should actually get rid of the Omnipod. I can't believe it made it through FDA approval. After an experience yesterday that almost landed me in the hospital--it malfunctioned because the cannula, shorter than a sewing needle, came out and I did not know it--I am returning it. I have only had it a week and am already thoroughly disgusted. And all that wasted expensive insulin. I have had diabetes since 1996 and all my HBa1cs have been under 7 percent with multiple daily injections (MDI). Nothing like this has ever happened to me before, and this is my first experience using a pump. What a disappointment! The endocrinologist wanted me to get the Medtronic Paradigm Revel pump with tubing and I opted for the Omnipod because I did not want the tubing. It's a great concept but it has too many kinks. I almost died from DKA once, when I was diagnosed, I am not willing to risk it again. And the PDM does not even tell you the cannula is out! Why is there no communication about that between the 2 devices? You'd think someone would have thought to put that in!

Here is part of a letter that I mailed to the FDA today:

I have used this device for only a week and am discontinuing the use of it and going back to multiple daily injections (MDI) after experiencing repeated failures with the pod. The product has serious design flaws that the company refuses to acknowledge or even address. The cannula in the pod (the pod is filled with insulin and the cannula pumps the insulin into the body) is smaller than a sewing needle and very easily comes out because of its size, and the adhesive used to hold the pod to your skin is rather weak. This morning, I woke up to a blood sugar of 366 because the cannula had come out and I was not receiving insulin. I gave myself a bolus, not knowing that the cannula had come out, and one hour later, when I checked my blood sugar, it was still 366. I realized something was wrong and wondered if the device was even working. Sure enough, when I checked, I found that it was not. I had no choice but to put on a new pod, even though I had replaced it ONLY 2 DAYS AGO because the other one had come out. You cannot reinsert these and therefore any insulin still in the pod is wasted, and insulin is very expensive!

Unfortunately, my blood sugars continued to elevate although I had put on a new pod. I had to call the doctor's office because the PDM (personal diabetes manager) was telling me that my blood glucose was so high it could not even give me a reading! At this point, I was feeling terrible and wondered if I should go to the ER. I ended up having to change the settings on the pump and also giving myself insulin shots to bring the blood sugars down to normal.

I no longer trust the device after this event. I have also noted that many events, such as when I changed the pods, are not even recorded on the history, despite my putting them into the PDM. To conclude, I am sending the device back to the company, as I am well within the 45 day return period limit, and I will get a better pump. I am going back to MDI until I do get a better pump because I am no longer willing to entrust my health to a device which I feel is highly unsafe. I would highly recommend that you re-evaluate this device. The company also provides little customer service after the initial training period and the trainer who was working with me is leaving the company. Despite her letting them know that she was leaving, no other trainer was assigned to work with me and I was just told to “call customer support” if there was a problem. I find this highly unsatisfactory as well. Their manufacturing processes as well as their complete recklessness in continuing to manufacture a product with dangerous design flaws should be questioned by the FDA.

Is there any pump that can tell when the cannula is out ? I know they can tell if it is occluded. How could a loose cannula be sensed ?

I'm glad, Newtopumping, that you acknowledge in your post title that your post pertains specifically to you, since I have had nothing but good, positive experiences with my OmniPod. I'm sorry your experience was so bad you felt you needed to write to the FDA about it.

I've been on the OmniPod for a few years now, and I've never had the cannula come out. I've also never had any "reckless" experiences with Insulet whenever I've called with questions. I've steadily kept my A1C hovering around 6 ever since I started using the OmniPod, and I was usually around a 7 with MDI.

The OmniPod, or insulin pumps in general, aren't for everyone. There's multiple pump options for a reason - some people adapt better to some than to others. And it's important to keep that in mind while making the transition from MDI to pumper.

For me, and for all of my diabetic friends who have transitioned to pumps, starting the insulin pump for the first time means a big life change. My doctor at Joslin's told me when I started pumping that flexibility is important, and sometimes you have to relinquish tight control for a week or two in order to get the pump tuned with your body and get even tighter control than before. Any pump you choose will take some trial and error at first, from boluses to insertion.

I hope you find a pump that works for you. And I'm sorry to hear about your OmniPod experiences.

WOW you have one single negative event, you give up and quit, AND send a letter to the FDA.
I would say that you either you were not sufficiently trained, or you barely read the material. What happened to you is addressed in the training and product materials. No alarm went off because your insulin was indeed being delivered, just not into your body. When your blood sugars remained elevated, you were supposed to check the cannula. You can also tell by the distinct smell of insulin around the pod and little droplets in the viewing area. This may all be to your own error in proper procedure. Also some people have better experience in different areas of placement (arms,legs,abdomen) You don't seem to be a good candidate for any pump. If you don't have the patience and motivation to give it more then a week, then I would stick with MDI. I for one, switched to the OmniPod over 2 years ago. I have had some pod errors, but far less then in the beginning. When I look at the total diabetes and A1C scores are far better then before with MDI. Writing a letter to the FDA before you gave it a fighting chance???? shame on you

Sorry that you had that experience! I guess I would only add that each user's experience with a particular type of treatment plan is going to vary--I have had great success with the pods and as long as there is a tubeless pump on the market I will never go back to anything else.

No pump tells you if the canula has been removed. The hope would be that you either notice it (smell of insulin, wetness at pod site (or infusion site for normal tubed pump)), or that the possible kink in the canula that would throw an occlusion error. It is not a completely fool-proof system--but no system (including MDI) is completely fool-proof.

And notes like "...many events, such as when I changed the pods, are not even recorded on the history..." Those items are accessable via the history, "all history", as evidenced in this photo of my pod change a few days ago (pod deactivated, pod activated a few minutes later).

I'm really sorry that there was an apparent "mishandling" with your education and subsequent lack of follow-up on the system, but that is not a typical user experience. I wish you the best of luck with minimed or animas (for what it's worth they have the same track record for training--it can be hit or miss like you experienced, but largely it is positive, much like the omnipod) or if you decide to go back to MDI for now.

So sorry to hear about your frustrations. It's tricky when first starting out on any of the pump systems but the fact you've only used this a week explains a lot. Any pump can have these same issues and more. Mine needed several adjustments before things smoothed out. All the pumps have small canulas and sometimes they do clog, insert wrong, bend,also occlusions, pulled out etc. are all issues pumps can have, it's a chance everyone takes with pumps and why it askes if the cannula has been inserted properly although I can never see it to tell. Bent tubing on the other pumps can also cause issues. I've always found customer support to be very helpful and if it's an error on the pods part, they will always replace for free.
I still have times when my blood sugar just sky rockets and I have to take shots to bring it down. I figure it's because I've inserted into an area where there is scar tissue or poor absorption or muscle instead of fat. Other times I can't keep my BS up! I have resorted to completely shutting down the pump for hours to keep it level. I always felt that using MDI was better only in that when I injected I was sure I was getting the insulin, with any pump it's really hard to tell.
Try and hold out and give it a few more weeks, 1 week isn't enough time to realy get the kinks out and you can still return it. I would ask your Doctor or call Omnipod and ask for a new trainer and go for another session with your concerns and questions.
I understand how frustrating it can be, it took me awhile to get comfortable with it. I don't believe they are "reckless" as there are thousands using the system with wonderful results and the approval from the FDA is not awarded lightly. The pump isn't for everyone, it took me 35 years to make the change.

Just a note: You can pull the insulin out of an old pod and reinsert into a new one when it gets knocked off early.

It seems that similar things can happen with tubed pumps too ... take a look at this new thread, posted by Spock:

Spock does note that it is the first time in 10 yearsthat this happened.

The tube came off the infusion set and was leaking insulin, leading to the same kind of situation you had. This is why people using pumps have to be alert.

For me, the pump brought down my A1C dramatically vs. MDI. But it sounds like MDI was working well for you.

Yes, a cannula shooting insulin onto, as opposed to into, your belly is one of the things you need to be aware can cause unexplained highs. Out of countless unexplained highs in my 8 years dealing with this, 4 on the oPod, an unattached pod has happened to me maybe 5 times.
I am sincerely hoping that one unsatisfied customer is not enough to sway the FDA! Good luck to you in finding your dream treatment. That is pretty much what we all hope for.

Don't think it can!

There's no way to sense that the cannula came out. Unfortunately all pumps (tubed or not) are like that.

How did the cannula come out? Was it exercising, an impact, or ... ?

Yes, all those events are recorded in the History log. Glad you posted it.

Many people use the new pod's syringe to pull the insulin out of a short-lived pod and reinject it into the new one, as barbraann pointed out.

I agree with the replies here. And personally think you have jumped ship way too early, and have went way overboard with your letter and theories on the omnipod.
Good luck with whatever you end up doing, doesn't sound like you have much patience or have taken the time to learn about the product you are using!!

wow, i will say that letter for the fda explains all for your patience using a product. do you do the same when there is a dull or bent needle doing mdi. when i have had a problem and did a mdi injection my bs come down a few points, it doesnt remain the same number. are you sure you calculated right for the high with the amount of insulin injection? only one week, wow, i dont know how anyone can expect so much in only one week.
anytime i get a product the first thing i do is read all the material and then ask questions that are not covered in the book or sometimes there is a solution that is different from the manual. Sorry to say but your not a canidate for the pump. I dont know if you have a cell phone but are you that frustrated when that dont work right or even your computer? just wondering.

Sorry you had problems…I’ve had it for over 3 years. I lover it!!!

I nearly ended up in the hospital because of this. What about that do you all not understand? I don't think it's jumping ship way too early. I need a pump that is reliable. My endocrinologist did NOT want me to get this pump and she was right. I am sorry it turned out this way, but I truly do not feel safe using this device. I have had plenty of training, but it will not stay on.

This is a very unfair comment. I have been on MDI for many years and never had a problem like this before. I nearly ended up in the hospital yesterday. My blood sugars went to well over 600, I found out later. That never happened to me in the 17 years I have had diabetes. Please don't be so judgmental. You were not here yesterday and did not see what happened to me.

Thank you very much for your nice reply, unlike some of the others on here. This is all new to me after 17 years of insulin injections. I loved the freedom of the pump, but having the pods repeatedly come off because the adhesive would not stay on is impossible. I think that is why the cannula came out. I was just lucky I did not have to go to the hospital yesterday. That is all I have to say on the subject. I think that should speak for itself.

I think this is a very rude comment. My blood sugars went up so high yesterday I could not even get a reading. This has NEVER EVER happened to me before, in 17 years of insulin injections, and I have always checked my blood sugars 4 to 6 times a day, and more, if I was ill or under stress. There are many complaints about the OmniPod on the Internet and several have already been filed with the FDA; if you look on their website you will find them. I am just lucky I did not develop DKA--I was on the verge of it, as I felt dizzy, nauseous and very sick. I also live alone, so I have to be very careful. I had DKA when I was first diagnosed and I was in a coma. I am sure you can understand that I do not want to repeat that experience. I almost died.

As I said before, my blood sugars went up so high that I nearly ended up in the ER. I think that speaks for itself, especially since I have never had that happen with 17 years of daily insulin injections.