Disetronic Pump warning letter to doctors

William C Biggs, MD

Registered User

Disetronic Pump warning letter to doctors

2003-07-26 01:00:34 PM
Greetings everyone,
You may recall the discussion thread last month about the FDA stopping the
sale of certain models of Disetronic pumps in the USA.
Now, a month later, I have received an "urgent" form letter from Disetronic
(a copy is at www.disetronic-usa.com/pdf/HCP_letter.pdf ), asking
that we not prescribe their pumps until further notice.
A copy of their FDA warning letter is at:
www.fda.gov/foi/warning_letters/g4120d.pdf
Disetronic has issued warnings on their D-Tron pump with stuck piston rod
problems and punctured keys at :
www.disetronic-usa.com/pdf/dtron_cust_final.pdf
Warnings about unexpected boluses with the H-Tron at:
www.disetronic-usa.com/releases/safetyinfo.htm
If you visit the Disetronic web site, an annoying little pop-up comes up
that tells you the units are not for sale in the USA.
Part of the reason that MiniMed, Animas, and Deltec have been innovating as
rapidly as they do is because Disetronic has been a tough competitor.
BTW, it was of some interest to me that the D-Tron used only Lilly pen
cartridges, even though Novo is the only insulin approved for pump use. This
may be a mere technicality, but I would have thought the FDA would have
required the D-Tron to either use Novo cartridges, or required that the
Lilly product get approval for pump use.
Any comments from users ? Are the FDA concerns valid, or is Disetronic
getting a bum rap here.
William C Biggs, MD
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Jim

Registered User

2003-07-27 04:13:34 AM

Re:Disetronic Pump warning letter to doctors

I have been using Disetronic pump for 9 years with very few complains but I
became very frustrated after receiving their "urgent letter" and recomending
to call their number (which it took about 3 hours to get connected and an
additional 35 minutes to hear a human voice) if there was a need to replace
the pump based on their warning - the joung man that I spoke with new very
little about what to do if I was looking for a replacement and, ended the
phone conversation without finding out what to do other than bying a new
pump from another supplier - I have been using Velosulin for 9 plus years
with good results, I don't know if this answers your question Doc. I was
also advised that Disetronic will be coming with a pump replacement around
midyear 2004 but on the mean time good-luck.
Jim
"William C Biggs, MD" <SCXQZNQKAJRC@spammotel.com>wrote in message

Quote

Greetings everyone,

You may recall the discussion thread last month about the FDA stopping the
sale of certain models of Disetronic pumps in the USA.

Now, a month later, I have received an "urgent" form letter from
Disetronic
(a copy is at www.disetronic-usa.com/pdf/HCP_letter.pdf ), asking
that we not prescribe their pumps until further notice.

A copy of their FDA warning letter is at:

www.fda.gov/foi/warning_letters/g4120d.pdf

Disetronic has issued warnings on their D-Tron pump with stuck piston rod
problems and punctured keys at :
www.disetronic-usa.com/pdf/dtron_cust_final.pdf
Warnings about unexpected boluses with the H-Tron at:

www.disetronic-usa.com/releases/safetyinfo.htm

If you visit the Disetronic web site, an annoying little pop-up comes up
that tells you the units are not for sale in the USA.

Part of the reason that MiniMed, Animas, and Deltec have been innovating
as
rapidly as they do is because Disetronic has been a tough competitor.

BTW, it was of some interest to me that the D-Tron used only Lilly pen
cartridges, even though Novo is the only insulin approved for pump use.
This
may be a mere technicality, but I would have thought the FDA would have
required the D-Tron to either use Novo cartridges, or required that the
Lilly product get approval for pump use.

Any comments from users ? Are the FDA concerns valid, or is Disetronic
getting a bum rap here.

William C Biggs, MD

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