Re: [IPk] Re: Help needed
> 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
> 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??
I don't think that is correct. The procedures for manufacturing
compliance for the EU and FDA are very different. My understanding is
that the FDA took exception on compliance issues that have been ongoing
for some time and when Roche acquired D, they lowered the boom.
Disetronic/Roche has been mum on the exact reasons so what I've just
written is entirely hearsay. There have been a number of QC issues, but
they don't seem to be different than what you can find in the on-line
records for the other pump companies. You will note that the EU took no
action and D has continued to sell both the HTron and DTron worldwide
except in North America.
To put it in perspective, the FDA was quite ready to allow Chiron to
deliver 50million doses of contaminated flu vaccine to American
consumers when the EU regulators closed down the plant.
We probably won't know exactly what transpired, but with marketing
affected only in the US (Canada??) while Europe and the rest of the
world have gone about business as usual, I doubt that whatever it was
was very serious.
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