Problems with medical devices (Insulin pumps, blood glucose sensors, meters, etc

Yerachmiel
By Yerachmiel Latest Reply 2015-02-05 06:39:48 -0600
Started 2013-11-26 13:24:19 -0600

https://www.accessdata.fda.gov/scripts/medwat...

Anyone using any electronic medical device should keep this web address (url) handy if G-d forbid they need it…

One of the reasons so many of our problems with companies and equpment do NOT get addressed is that we report to the company and think they are very good "citizens" and will immediately follow the law and report any potentially serious problems ot the FDA. it turns out that many companies (I am not venturing to guess who or what, can only speak of the cases and companies I know) are NOT reporting the events, they are not collecting the followup information that should be provided to FDA (for example - did the event result in a hospitalization or a doctor call or visit? Did it result in an Emergency Squad call? what remedial steps were necessary to address the result of the event?

I have had a pump for over thirty years and have never had to obtain this address or use it before. When I looked at the FDA site and pulled up the company and reported problems, the vast majority of cases I kow about are not even listed!!

If you are having a problem with a pump, meter, sensor or any other medical device, you should report any adverse effects you have to this web site and keep records. It is the ONLY way that we will be able to get the comanies that are supposed to be taking care of us to comply with their federal requirements on reporting and fixing of problems!!


2 replies

JesseStreeter
JesseStreeter 2015-02-05 06:39:48 -0600 Report

Well thanks for sharing it. Diabetes is a severe disease in which our body is not able to regulate the amount of sugar in blood either because of inadequate insulin production or the inability of body's cells to respond insulin properly.

Today there are lots of medical devices like you have mentioned above and those out there in the market for continuous monitoring and control of glucose, but it is true that many problems occur in such devices. It is important to use only high quality and medical regulatory approved product of companies like you can see at ilexmedical.com etc. which are manufactured looking towards all the security purposes.

Even if you are facing any concern with the medical devices, it’s good to contact directly to medical device regulatory board instead going anywhere else.

Just Joyce
Just Joyce 2013-11-26 17:07:08 -0600 Report

I will go directly to the FDA, FCC etc…for problems and since we have a very good Consumer Protection agency, I report to them also.

The reson problems with equipment aren't addressed is that people won't speak up for themselves. They will tell everyone but the company or the FDA. They also don't want to follow the steps required to complete the report or do a follow up. As I always say, it is easy to sit on your butt and complain. It takes energy to do what is needed to take action on the complaint.