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[IP] (Fwd) RE: Disetronic posting re. FDA recall
Pumpers and Friends,
FYI, I received this nice letter from Disetronic regarding the recent
series of posts about the DTron and their voluntary recall. I think
this letter makes pretty clear what occured and what was done about
it. If you have further questions, contact Mr. Laan directly.
##############Disetronic letter follows###################
Subject: Misunderstanding about Disetronic's voluntary recall of
the D-TRON insulin pump
From: Rem Laan, Director of Marketing, Disetronic Medical
Systems, Inc. email @ redacted
To: All IP list members
It has come to my attention that there is a misunderstanding about
Disetronic's voluntary recall of the D-TRON insulin pump. What occurred is
This spring a number of D-TRON insulin pump customers reported receiving
small (.5 to 2 unit) unintended boluses from their pumps. Upon investigation
we determined that in a small percentage of pumps the buttons were defective
and did not spring back when pushed. Therefore, on June 17th we sent a
letter to all D-TRON insulin pump customers alerting them to this potential
problem and providing them with troubleshooting tips. At the same time we
also notified every physician who had prescribed a D-TRON insulin pump,
every distributor who had sold a D-TRON insulin pump and every one of our
network of certified pump trainers in writing about this potential problem.
On July 18th a second letter was sent to all D-TRON customers explaining the
process by which we would be bringing their pumps in for testing. This
process is on-going, and when testing indicates the buttons on a pump may
fail prematurely, we repair or replace the pump at no charge.
This was a voluntary recall, initiated by Disetronic, because product safety
and customer satisfaction are our number one priority. It is the same
"recall" as the one recently listed on the FDA web site. We believe our
customers should know about problems if they occur. That's the standard we
live by. And, that's why we did what we did.
If you have any questions or concerns, please do not hesitate to contact me.
My e-mail address is:
email @ redacted
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