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Re: [IP] Re: Disetronic D-Tron Plus freebees



Michael,

 You disappoint me in understating the serious position that Roche & Disetronic
has put itself and its customers into by its deficient practices. This is far
more than just a misunderstanding over paperwork vis a vis the practice of fine
swiss watch making.

 I really am sick of the old conspiratorial diatribe that the FDA is out to get
Disetronic. This has been discussed and dissected before on IP and the fact that
people are still choosing to ignore the facts is disturbing. Fact is I can
attest to personally that my area Disetronic rep was telling me that the pump
was ready for release in the 1Q 2005 as early as November/December
2004....nearly 9 months before the FDA even inspected their Burgdorf facility.
Prior to that, and just after the FDA importation ban I was told that Roche was
going to build the Spirit pump in Indiana to circumvent the import ban. I don't
like being lied to on the basis of keeping me as a potential customer.

 These links should give you the proper historical record as to why Disetronic
is barred from importing pumps into this country:



http://www.insulin-pumpers.org/cgi/archives/mail-insulin-pumpers/Jan2006/msg00629.html


http://www.insulin-pumpers.org/cgi/archives/mail-insulin-pumpers/Jan2006/msg00651.html


http://www.insulin-pumpers.org/cgi/archives/mail-insulin-pumpers/Jan2006/msg00599.html


>> >Just my opinion.... Roche/Disetronic is a fine company as are its
>>> >competitors. WAS a fine company, the operative word unfortunately is
>> >WAS
>>> imo.Roche/Disetronic deserves better treatment from the FDA.  


>> Michael,
>> Do you have
>> some special insight that the rest of us have not been privy to?  Or is
>> this opinion based on their corporate donations to IP?  As a Customerof
>> Disetronic Medical Systems since 1999 I have seen little but a sharp
>> downwardtrend in their service and communications to customers.Nothing
>> has surfaced in the years since the FDA importation ban to counter
>> thecharges of lax manufacturing by Disetronic.  If anything, the
>> oppositehas occurred as Disetronic has had to recall many of its
>> consumable items (since the FDA importation ban)and as in the case of
>> D-TronPlus they used nothing more than surface glue to attach the
>> silicon buttonguides to the pump's surface.

>the problems that Disetronic have been having with the FDA are no 
>secret and have been posted to this list several times. As best as I 
>can reconstruct the issue it is as follows (I'm no expert, so someone 
>step in and correct any inconsistencies I introduce): The problem stems 
>from a disagreement about paperwork and their manufacturing process 
>several years ago. The EU regulatory body and the FDA have differing 
>rules on the manufacturing and tracking process for pumps. The 
>HTron/Dtron series pumps were manufactured the "old fashioned" way by 
>craftsman, much like a fine swiss watch. The FDA dictates that an 
>automated line be use where each mfg step is done in the same fashion. 
>This eventually led to Disetronic being barred by the FDA from selling 
>product in the US. Along comes the Spirit pump. This pump is 
>manufactured in a manner which as I understand it is in full compliance 
>with the FDA rules. The FDA has inspected the new mfg facility and as 
>far as I know has not said there are any problems. Neither have the 
>agreed to let D proceed with selling the Spirit in the US. In addition, 
>I've heard rumors that some heated words were exchanged at high levels 
>between D and the FDA. The net result is that the FDA has not issued a 
>finding on their inspection conducted man MONTHS ago. Bottom line, this 
>has been going on for several years and I believe it is "payback" by 
>someone in the FDA for a grudge against D..... but.... that's just my 
>opinion.
>
>Michael
.
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