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.