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[IP] FDA stops sale of insulin pumps, paperwork why!!!

Pumpers and Friends,
    This is a bad thing to stop people from getting a pump over a paperwork
problem. There is NOTHING medical wrong with the disetronic pump, why does
the FDA stop the sale of a pump .... over a paperwork problem... so  fine
them some money and tell them to fixed the paperwork.

                            REMEMBER TO SMILE AND BE HAPPY

----- Original Message -----
From: "Michael" <email @ redacted>
To: <email @ redacted>
Sent: Thursday, June 19, 2003 1:55 PM
Subject: Re: [IP] FDA stops sale of insulin pumps

> > NewsFlash:
> My interpretation of this based on conversations with the people
> involved is that the FDA has its tail in a knot over differencex in
> the EU vs US standards and reporting and that Roche / Disetronic is
> an innocent victim. Frankly I think it is an example of heavy
> handedness on the part of the FDA over paperwork issues.
> Roche/Disetronic is in full compliance with ISO standards that all
> pump makers adhere to. While I don't champion any particular
> manufacturer, I think it's a shame that a fine company has to suffer
> from the incompetency of our own government agencies.
> Michael
> >
> > FDA Stops Sale of Insulin Pumps!
> >  Senior Disetronic representatives reported that the FDA has issued
> >  an embargo
> > on importation of new Disetronic insulin pumps into the United
> > States. On Monday an official letter was issued, however private
> > conversations with a high level Roche representative indicated that
> > they knew about this previously.
> >
> >  In fact Diabetes in Control has learned that Roche has already sent
> >  members of
> > their manufacturing teams to Switzerland to take over operations.
> > The embargo is seen as a result of continuing problems with
> > documentation of the manufacturing processes, and back end
> > procedures of the company.
> >
> >
> >  The FDA has in no way indicated that there is a safety issue with
> >  any of the
> > pumps that Disetronic makes. Although the embargo means that new
> > patients cannot be started on Disetronic insulin pumps. The FDA
> > action does not affect the ability of Disetronic to provide support
> > to existing pump users.
> >
> >
> >  I met in private with Disetronic representatives at the ADA meeting
> >  last week
> > to find out what they will be doing and was informed that they will
> > continue servicing current customers and will help patients waiting
> > for Disetronic pumps select an alternative pump from another
> > company. ----------------------------------------------------------
> > for HELP or to subscribe/unsubscribe, contact:
> > HELP@insulin-pumpers.org
> ----------------------------------------------------------
> for HELP or to subscribe/unsubscribe, contact:
> HELP@insulin-pumpers.org

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