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RE: [IP] How and where to report a dead Pump to the FDA

Eric Grossman [mailto:email @ redacted] 

>  My Paradigm died this morning. No clue why no error just 
> dead. I have seen talk
> of being able to submit a report to the FDA and would like 
> to. Any directions
> would help.

The FDA web site is http://www.fda.gov and there's a link to "Devices". 

But I doubt that any one occurrence is really of interest to them unless the
adverse effect involved serious impact up to and including death (since you
wrote this, I would guess your case doesn't qualify).  QA/QC does *NOT* mean
zero defects.  It means that the defects in devices are kept to a particular
rate, and that includes so-called catastrophic failures in which pumps stop
working altogether.  Manufacturers are required to keep records of failures
that are reported to them, as well as how they rectified the problem.  IOW,
Medtronic/Minimed is the proper contact to report your problem.

Jim Handsfield
email @ redacted
The opinions expressed are mine alone and do not necessarily represent those
of my wife who runs our house and makes more important decisions than I do.
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