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[IP] FDA stops sale of insulin pumps


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.
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