[Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy Diabetes care

Mike Freeman k7uij at panix.com
Sat Aug 31 20:16:19 UTC 2013

Amen, Dotty.

Is the Hungarian meter available in Great Britain? The SensoCardPlus hasn't
been available there for many years and the firm never got very far
submitting a FDA 510(k) application. I must say, it was the only meter
allowing one to delete readings, assuming that we, the customers, had some

But, as you say, we want to have our cake and eat it two, desiring
"accuracy" (whatever that might mean), speed and little blood. I'm afraid
perfection happens only in Heaven.

Mike Freeman

-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
Dorothea Martin
Sent: Saturday, August 31, 2013 12:28 AM
To: diabetes-talk at nfbnet.org
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy
Diabetes care

Hello, Mike and All,
It seems to me thatr any glucometer which gives the diabetic a false reading
t rather than the information that there is not enough blood on the strip
would come under the FDA's umbrella of concern. That description fits most
talking glucometers. The problem as I see it is that we need to have our
cake and eat it too on this one. We need a gadget which is cheap electronics
so that our insurance will pay for it, but we need it to have the accuracy
and the large memory of a professional machine, one that we couldn't pay for
and wouldn't want to carry around if we could. I am concerned that this FDA
effort to raise the bar will unwittingly knock out talking meters. The only
talking meters which do not have this problem are the new AutoSense Plus,
made in Hungary and not sold in the US, and the BioSense meters. Now if we
remove the Hungarian meter from consideration, that leaves American
diabetics with no choice, and what is more dangerous, no competition.
Dotty Martin

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