Diabetes Self-Management Blog

For many people with diabetes, insulin pumps are an essential tool — offering better blood glucose control, more flexibility in the timing of meals and exercise, and greater independence from syringes, vials, and pens. But insulin pumps also carry risks, such as the potential for an infusion set to fall out or for the pump to malfunction, delivering too much or too little insulin. As the popularity of insulin pumps has grown, so has the incidence of such “adverse events.”

According to an article from HealthDay, since 2006, 12,093 injuries and 310 deaths associated with insulin pumps have been reported to the US Food and Drug Administration (FDA). This, combined with 4,294 reported pump malfunctions and several recalls of pumps, prompted the FDA to convene an advisory panel of outside medical experts to make recommendations for how to deal with the issue. The panel concluded that the FDA should require pump manufacturers to provide more detailed information on adverse events. Currently, according to the panel, manufacturers often do not mention what specific pump difficulty occurred in the adverse events they report, and they even frequently give incomplete information about deaths associated with their pumps. Thus, the reason for most of these deaths remains unknown. By requiring manufacturers to be more detailed in their reporting, the panel hopes, both manufacturers and the FDA will have more information to figure out — and solve — potential pump problems.

If you use a pump, have you ever felt in danger because of a mistake or malfunction? Do you think pumps are more dangerous than traditional insulin injections? Can you think of any tips — for manufacturers, health-care providers, or pump users — that might reduce the likelihood of mistakes? How much should pump manufacturers be held responsible for mistakes made by users? Should they be required to investigate every potential pump-related injury or death in detail? Leave a comment below!

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Comments
  1. one problem i had with my pump when i first got it in HS was that the infusion site was not working properly - the insertion part was ‘bent’ under my skin preventing any insulin (or at least very little) to enter my body. the pump did say a few times that it was not working properly but the site felt fine so i would re-do the bolus and it seemed ok. well it wasnt. i of course ate lunch that day and due to not having an adequate meal bolus went in to ketoacidosis. i think the pumps now more rigorously demand that a site be changed with more frequent beeps than what I can remember on my very first pump. either way, that was a very scary situation - i went to the hospital and was dehydrated along with a BS of about 600.

    Posted by mandy |
  2. As a new user of the insulin pump, I would love to hear a beep after the infusion set is in place and everything is good on a site change. To wait 2 hours afterward for a BG reading.Is rather mind boggling. Just a prolonged beep to tell me that it is working correctly. It can do almost everything else and there are beeps for everything else. That would be great.

    Posted by Ruth Flowers |
  3. I have a pump and I love it! Four years with it and all is well!

    I would like to see more educational classes for pump users / Type 1 diabetics. When I have a concern or question I have to call the pump company and sit on hold forever and a day for some simple advice or a quick question! My insurance company pays for educational classes and all of them are geared towards type 2. I am always the only type 1.

    Posted by Samantha |
  4. The biggest danger is the fact that the pumps use very fast acting insulin that has a relatively short duration- roughly after 3 hrs the insulin is gone in your body. If the pump stops working for any reason (such as it unkowingly getting disconnected) within a very short time span the user can have sugar levels rise to 6 times the normal amount. (because he or she has “dried out” of insulin completly). This quick rise can cause a dangerous medical condition to occur a lot quicker than a person miscalulating injections.

    Posted by Sid Samuels |
  5. I have been on insulin pump therapy for 5 1/2 years and have experienced several adverse effects. On the most recent problem my blood sugar dropped so very quickly that I didn’t have time to react and my husband had to call 911. This happened right after I had dinner and was cleaning up the kitchen. I felt funny so I went to check my blood sugar but was unconcious before I knew what was happening. On two previous occasions my blood sugar shot up to over 500 when my infusion set came off during the night.

    In spite of these adverse incidents, I am pleased with the overall control that I get with pump therapy. It has brought my blood sugar control to much better than it was on insulin shots. It also allows me more flexability in choosing when I want to eat rather than when I had to eat.

    Posted by Patricia Thomas |
  6. I have used an insulin pump for 12 years. Two different manufacturers. I took injections for 10 years before that. First, manufacturers should only be held accoutable if there is a malfunction in the device….not if the insertion set is not in correctly, or the patient uses the pump incorrectly. I have had several issues with my pump therapy, but all of them have been due to something I did or didn’t do. Like checking your blood sugar before meal or exercise. Don’t make this another case of it’s somebody else’s problem!

    Posted by Teresa |
  7. I feel pumps give MUCH better control. I am both a pump-wearer and diabetes educator. Prior to becoming an educator, my own A1C was deplorable. I felt I could control my diabetes just fine with insulin vials and syringes, and do it all myself.

    That was with an A1C of about 12. After capitulating and going on the pump, I utilized the ‘insulin on board’ feature, the extended bolus feature and the EZ carb calculator, and my A1C, while not perfect, is a 7.4. With significant hypo unawareness, I am happy with a 7.4.

    Pump wearers need to be aware of the dangers involved in wearing a pump, as well as being educated on the challenges that may come with pump use. As a pump trainer, I wish each individual to be placed on a pump had to undergo a ‘common sense’ test to see if they can troubleshoot when problems arise. If not, then give more education, if it still does not work, then I would preclude them from pumping. OR! Make it mandatory for pump use to coincide with CGM use. My CGM has allowed the 7.4 A1C.

    Some people are just not candidates for a pump. It is not a sign of failure on the health professionals’ part if someone cannot ‘get it.’

    Posted by Joan |
  8. I wanted to give a warning about a stupid mistake I made a few months ago. I had changed my location in the middle of the night due to my husband’s noisiness. There was no clock in the room I moved to, so I bagan pushing buttons to bring up the backlight on my pump so I could read the time display. It was too dark to identify the right button, and I started hearing a clicking noise. Sure enough, I had given myself an unnecessary bolus of a few units of insulin. I had to get up and snack to counteract that bolus.

    Posted by P. Mooney |
  9. I have a pump and have had it for more than 4 yrs. I CHECK my sugars 8-10 times a day…If you do this you should be on top of you numbers and if there is a problem and you continue to see it you can call the company or your doctor for help. Continuous lows or highs if you are following the set up correctly should be able to be found early and corrected. If you DO NOT check your sugars often then there could be a problem…MEDICARE is a problem because they want you to only check you sugars three times a day . Without a doctors note they will not pay for supplies. The more you check the healthier you will be and the more in control you will be…Pump people are available 24-7 if you have a problem and there is a 24 hr insulin if your pump should have a problem which you and your doctor should have discussed. If you as a diabetic want to be healthy YOU have to work at it.

    Posted by Pat Knoll |
  10. Pump users should be aware when the pump is NOT delivering INSULIN into your body. It should send a warning of some sort so that the user knows what is happening.

    Posted by sylvia |
  11. I have been on the Animas insulin pump for eight years & had one bad incident. Diabetic problems occur for me always late at night between eleven and one I don’t know why. My pump did malfunction causing a hugh rise in blood sugar & I didn’t know what to do, after doing all the reasonable things, like changing the site & etc. calling Animas for help.
    But the one thing I learned from this. is that every pump user & diabetic should have a backup plan and be shown how to make an injection, have syrines on hand and know when to use them.

    Posted by sandra kiblin |
  12. I have been in danger because of a mistake I’ve made, but no worse of a mistake than I could make with a syringe and a vial. Pump companies should continue to be required to investigate and to plainly state the causes of the injuries and deaths in detail and to be pro-active in advising their customers of the possibilities of injury and death from mistakes and malfunctions. As to being held responsible for the mistakes made by customers, only in so far as their failure to advise the customer of those possibilities.

    Posted by George Lovelace |
  13. We have used a Minimed pump for our 6-year-old for about two years. Our biggest problems have been inconsistency of insulin dose delivery and site rejections. We also have been concerned about scar tissue forming at the infusion sites that would possibly require medical interventions in the future.

    Posted by TZel |
  14. I’ve been a pump user since 1988. In that time, only one incident occured with tubing clogged (1991) which raised my Blood Gluose to a level that I needed to take action and asked a friend to take me to the ER (I was very conscious of what was occuring but thought I was ill with the flu.) Now if I have more than one elevated BG in an hour, after bolusing for the high, I change the infusion set. That said, I believe this issue is a personal responsibility. Would I like to know what manufacturers “adverse reactions” are? Yes, but ultimately it is our responsibilty. How is this different than using a pen or a shringe to inject insulin, I know people that give too much or too little and have highs and lows just as I have. I was instructed how to take care of myself when I started on the insulin pump. If you don’t check your BG several times (I check 7-8 times) per day, then a lot of things can occur. Again, we must be the responsible person in taking care of our health concerns.

    Posted by Bev |
  15. I know this is an extreme example, but I figured I would add it since I just met this lady… I met a fellow pump-user the other day, and she told me how much she loved her pump, but how it DID cause a major problem in her life. She said that her pump leaked battery discharge into her (I believe), and it ended up causing a heart attack and complete kidney failure. Her BG was an 1100 when she got to the hospital. She said she was there for 11 days, and her pump company sent representatives to meet her. They paid her bill without her asking.

    With that being said, she also had it back on. She said she went 6 months without it, but ended up deciding the convenience of wearing it outweighed the risk.

    I’ve been a pump-user for going on two years. So far no major problems… though her story was a little jarring. :O)

    Posted by Nicky |
  16. I had an interesting thing happen last week. After being gone on vacation for 2 weeks and thru several time zones. I kept experiencing lows in the morning(45-60’s)and highs (200-400) in the evenings, the more I corrected the worse it got until I realized somehow thru all my time zone changes I had inadvertantly switched my am and pm on the pump. So I was getting more insulin when I should have been gettig less and vice versa. A simple upside down until I changed the am and pm correctly.

    Posted by Marie |
  17. I have had a pump9 Mini Med) for more than 10 years now and only had 1 problem and the company with in 24 hrs. had a new pump to me, I would never go back to a needle.

    Posted by Thomas Ward |
  18. I am a new pump user (under a month) and so far, I hate it. I change the infusion site, and most times my bg soars. I then have to change the site. That is really iffy as to being successful. Today, I had to change the site 3 times (per the 24-hour helpline). So I test my bg 8 times a day, my bg is not consistent (today 104 upon waking and 556 before dinner). I have had lows of 47 and highs over 600. Does ANYONE have a suggestion about where to site the infusion set? Any suggestions on how to get this thing to make me more consistent? Any idea of how long it takes to have control?

    Posted by Pat |
  19. I use an insulin pump (accu-chek combo) for my 18 month old. Although it feels slightly overwhelming how much information you need to learn (however this could be because he was very recently diagnosed) I love it. His bg’s have been brilliant.
    However we had a problem tonight where his BG kept rising I rang the doctor and they recommended a manual insulin dose and tube and cannula change. All now seems well.
    I don’t think the companies should be held responsible for users mistakes,but they should maybe include a separate trouble shooting leaflet with problems that have occurred to other users, symptoms of the problems and advise on how to rectify.

    Posted by laura |
  20. This sounds really stupid (and I doubt it would be good for you) but I wish they could add a dye to the insulin so it would be really easy to see if there are any blockages in the tubing. We are experiencing a few strangely high bG’s again (whilst he is asleep so not because of miscalculated carbs) I’m looking at the tube thinking it looks like its completely empty down to the pump(but the truth is its probably fine).

    Posted by laura |

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