October 3, 2003
Insulin Pumps
Question from New Bern, North Carolina, USA:
About a year ago, I upgraded my insulin pump to a new model, and ever since, I have had problems with my pump along with the service provided by the company. From software glitches to improper pressure in the reservoir, I have had three replacement pumps (for a total of four pumps) all with problems. Often these problems have resulted in extremely high blood sugars.
While the customer service reps at the technical service line are very sympathetic and informed, their management seems to be lees than concerned that my health is deteriorating as a result of their faulty product. I have spoken with my local sales rep, various customer service reps and even a customer service manager. My requests seem to be falling on deaf ears. The only thing they are willing to do is send me yet another “refurbished” pump.
I noticed you recommend calling the FDA which I will do that today. In the meantime, do you have any suggestions as to how I can get a pump that actually works properly? Do I have any recourse? Thank you for your help! I am at my wits’ end!
Answer:
Whenever you have a problem with a medical device, you should discuss it with the device maker, your physician, and possibly your insurance company. Your physician could assist you in discussions with the company to ensure that you get a device that works as advertised and is safe. Your insurance company could also assist, since they paid for part of the device.
If you are unable to work out the issues with the company through direct contacts or with the assistance of your physician and insurance company, you should contact the FDA to report the problem. Reporting instructions are available on-line at the FDA website. The process of reporting adverse events is now on-line at MedWatch Online Reporting Form 3500.
Regarding your question about getting a working pump, you could always revert to your old pump. I realize that this is not necessarily the best solution in the long run, but it always an option.
JSH
