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[IP] Official statement from Disetronic RE: FDA

Hello everyone,

Below is the "official" word from Disetronic that I received this 
morning. I suspect this is all that they can say about the matter. If 
you read my email of yesterday, you know what I think of the FDA's 


On Wednesday June 11th, the US Food and Drug Administration (FDA)
issued a formal letter that raises concerns about the manufacturing
processes for infusion pumps distributed by Disetronic Medical
Systems, Inc. 

The letter means that infusion pumps manufactured in Disetronic's
Burgdorf, Switzerland facility may be detained upon entry into the
United States and prevents Disetronic from distributing these infusion
pumps to new U.S. customers until the FDA's concerns have been

We will continue to support all Disetronic pumps currently in use in
the market. Current customers will continue to receive the service,
support, and disposable products they require to continue using their
existing pumps.

Disetronic, with established process and quality expertise provided by
Roche Diagnostics, is already taking action to remedy this situation
and will continue collaborative efforts with the FDA to implement a
complete action plan.

We are committed to the highest quality products and services to
ensure your safety and well being and will provide ongoing timely
information to you. In the meantime if you have any questions please
contact us at 800-281-1986.


Disetronic Medical Systems, Inc.
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