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RE: [IPk] Re: Help needed



Julian and the person who wrote to Julian:

RUBBISH. That's absolute rubbish. Shortly after the Roche acquisition in 
2003 Disetronic got a US FDA embargo on further sales of its pumps for 
having poor quality assurance/documentation procedures at its Swiss plant, 
NOT for patients having had health scares because of its pumps.

The person who wrote to you, Julian, is conflating 2 entirely separate 
issues into a cause-and-effect scenario that is wrong. He or she may not 
have personally invented it. The story may well have been received from a 
trusted source. The idea that Disetronic pumps have been banned in the US 
has been deliberately perpetuated by some industry/medical care 
professionals in order to undermine Disetronic's reputation. This is unfair 
and malicious.

Disetronic are still selling supplies and servicing existent pumps in the 
US. NO US DISETRONIC PUMPERS HAVE BEEN MADE TO RETURN THEIR DISETRONIC 
PUMPS. Making people return something in a complete field-correction recall 
and forbidding the company to do further business is a ban; telling a 
company it can't do further business until further notice but it doesn't 
have to replace all its products in users' hands is an embargo. Disetronic 
got embargoed, not banned.

Disetronic have made tremendous headway with the FDA in the past several 
months in preparation for the launch of the new Spirit pump. Does anyone 
think that Disetronic would develop a new pump specifically for the European 
market, famed for low reimbursement levels and limited numbers of people 
going on insulin pumps? The global economy is bigger than the EU and anyone 
who doesn't realise that needs a subscription to the Economist.

The issues of overdelivery go back to the early/mid-1990s, when the air 
pressure regulation technology and waterproofing standards were not what 
they are today. Technically, anyone's pump can malfunction at any time, but 
all problems that might be anticipated are taken into account in R&D. 
Disetronic didn't anticipate the problems that led to the overdelivery but 
once the issues became apparent changes were made. Otherwise Disetronic 
would not be allowed to do business _anywhere_. The EMEA would certainly 
have intervened by now if any insulin pumps were deemed seriously dangerous 
and wouldn't the NHS would just love to withdraw pump funding based on 
safety concerns? Anything that's bad for one pump company is bad for them 
all when some diabetes nurses in the UK think that Medtronic and MiniMed are 
competing companies (I've heard of this a few times).

Okay, early morning rant over.

Melissa
Type 1 11+ years; MiniMed pumper 7.5 years; Animas pumper 1 year 1 month

----Original Message Follows----
From: email @ redacted
Reply-To: email @ redacted
To: email @ redacted
Subject: [IPk] Re: Help needed
Date: Mon, 31 Jan 2005 15:39:31 -0800

Hi All

  Thanks for all of the help and advice you gave me regarding this subject, 
on
and off list. A paticular thanks to John Davies who rang me at home, in his 
own
time, and gave me very helpful advice. In a situation like that it is always
reassuring to speak to someone who knows what they are talking about.

  I started using the spare pump with a BM of 18.9. I put my basal rate up 
to
150% for 2hrs and gave a bolus of 8 units. By 9pm my BM was down to 11.6. By
11pm it was down to 10.9. Woke at 6am(Monday) to a very comfortable 7.5.

One of the off list e-mails I received stated "diesetonic have been
banned in the USA for quality control problems and
'over-dosing".  Does anyone have any info on this? Melissa??

Once again, thanks for helping me out everyone.

Julian
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