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

Dorothea Martin bestsinger at samobile.net
Sat Aug 31 07:27:38 UTC 2013

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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