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RE: [IPk] Re: Help needed



>Disetronic are still selling supplies and servicing existent pumps
>in the US. NO US DISETRONIC PUMPERS HAVE BEEN MADE TO RETURN THEIR
>DISETRONIC PUMPS. Making people return something in a complete
>field-correction recall and forbidding the company to do further
>business is a ban; telling a company it can't do further business
>until further notice but it doesn't have to replace all its products
>in users' hands is an embargo. Disetronic got embargoed, not banned.

I have here a letter from Disetronic dtron_cust_final.pdf which I 
downloaded from their website on 18 Sep 2003. It says:

"The Food and Drug Administration (FDA) inspected our insulin 
infusion pump manufacturing facility and determined that our 
manufacturing processes are not in substantial compliance with the 
regulations.  In the absence of compliance with these regulations, 
the reliability of devices cannot be assured, which could potentially 
result in problems with the product leading to over and/or under 
infusion of insulin.  Based on our discussions with the FDA and our 
evaluation of the observations, we have decided not to ship 
D-TRONplus insulin pumps to any new customers until we have improved 
our manufacturing processes to adequately ensure the reliability of 
our pumps for their intended use.  Some of the problems that have 
been reported include stuck piston rods and punctured buttons.  Pumps 
that do not perform reliably as expected may lead to hypoglycemic or 
hyperglycemic events, the symptoms and actions for these possible 
events are described on page three of this letter. The FDA has asked 
that we inform you of the problems with this pump so that you can 
make an informed decision regarding the continued use of your 
D-TRONplus pump.  If you wish to discontinue use of your pump, have 
your pump replaced, or have questions regarding your pump, please 
refer to the "Actions" section of this letter."

Bear in mind this action is only in the US and Canada. Some claim 
this is the US government protecting their own internal manufacturers 
of insulin pumps with spurious regulations. Others deny this. Make up 
your own mind. I guess groups like this are good for the open and 
honest exchange of opinions. There is an excellent list of pumps 
available in the US at 
<http://www.diabetesnet.com/diabetes_technology/insulin_pump_models.php> 
For a while Disetronic was removed from this list, but it has now 
been put back on.

Julian - I was curious that you didn't swap straight away to your 
spare pump when you suspected misbehaviour with your pump. There we 
are.

John
-- 
mailto:email @ redacted
http://www.webshowcase.net/johnneale
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