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

[Mike Freeman]

Bernie:

I didn't see any quote here and often when I look at your messages on my
iPhone, I have to punch a "hidden message" button to see your replies. What
mail client are you using?

On the matter of diabetes device design, I feel compelled to caution all of
you (Dotty and others) that development of a separate speech box won't make
a spec of difference in the process for talking meter approval: the FDA will
insist upon testing the box with *each* meter with which it would purport to
work before issuing 510(k) approval to market the box with any meters -- and
it will allow marketing of the box to work *only* with the meters it has
tested. This seems daft to us in that we think it's perfectly reasonable to
separate data access from the accuracy of the underlying devices. But it is
we, the public, who have insisted upon such tests and devices and it seems
perfectly reasonable, perhaps rightly, to most people to test the combined
system of meters and display devices (for that's what a speech box really
is).

I know we're looking for easy/cheap/simple solutions and for villains whom
we can castigate for their perfidy. But there aren't any. Even the FDA's
carping in the Prodigy warning, valid as it may be, is unrealistic. For
example, it cited Prodigy for not supplying lot numbers of strips that
purportedly were giving trouble. But how many of you know what your strip
lot number is? How much better if the warning had concentrated on improving
control procedures and asking Prodigy who would be fired if mistakes weren't
immediately caught before strip release?

So let's put our thinking caps on and come up with suggestions that will
bear fruit in the current political and regulatory climate. After all, we
have been chosen to deal with the here-and-now, not utopia.

Mike Freeman


-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
Bernadette Jacobs
Sent: Monday, September 02, 2013 9:39 AM
To: Diabetes Talk for the Blind
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy
Diabetes care

On 9/2/13, Mike Freeman <k7uij at panix.com> wrote:
> You assume that there is a common protocol for communicating data via 
> USB port. Without legislation dictating otherwise, I think it more 
> probable that each manufacturer would end up insisting upon developing 
> its own speech box and I deem this unlikely these days. We have the 
> example of Roche which supposedly was doing just this, making a 
> combination of an AccuChek Aviva and speech box. The meter was 
> supposedly going to be a standard Aviva but this didn't work out. 
> Roche had to modify the meter and we have heard nothing more of the effort
for several years.
> I agree with Dotty that we should be willing to pay more for our bg
meters.
> We would have to change our mindset. And people tend not to want to 
> test now, let alone if meters were more expensive. And the current 
> marketing model in the industry is that money is made on the strips, not
the meters.
> Fun and games.
> Mike
>
> On Sep 2, 2013, at 3:15, Cherylandmaxx <Cherylandmaxx at hotmail.com> wrote:
>
>> Biosense should also
>>
>>
>> Sent from my Samsung Galaxy SR4
>>
>> -------- Original message --------
>> From: Dorothea Martin <bestsinger at samobile.net>
>> Date: 09/02/2013  3:46 AM  (GMT-05:00)
>> To: diabetes-talk at nfbnet.org
>> Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to 
>> Prodigy Diabetes care
>>
>> Hello, All,
>> If we want true fidelity in a music recorder, we pay $300 and 
>> something to buy the LS-100. But somehow we expect to get a complete 
>> kit for a low price and have it be accurate in testing our blood. 
>> There are accurate meters. |I think that the Bayer Breeze2 that I 
>> have used with sighted help is accurate, but half of its memory does 
>> not have to go into speech. I think it's time to move the speaking 
>> function back to another gadget, as with the Accu Check Voicemate or 
>> the IBG Star, where the iPhone does the speaking. What the good folks 
>> at |Prodigy should do is to make and sell such a device so that we 
>> could use almost any meter that has a USB connection.
>> Dotty Martin
>>
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Hey Gang:

I like where Mike and Dotti are both going with this one.  Most of these
outfits are giving away their meters anyway, no matter which one of them for
the very reason so that we don't have to buy it.  Could it actually be that
these folks are giving away their meters because they are so inexpensive
that the cost really doesn't matter to them.  So, if there was one out there
that was more accurate, no matter the price, would they be so inclined to
give meters away?  Don't worry.
If the price was high enough, they wouldn't give any of it away.  They
wouldn't really care whether or not anyone could afford it.  If it was high
enough and if we really wanted it, we'd pay the price.  Right?
That's the way most do it.
We took the kids to the Grande Prix here in Baltimore.  For three slices of
pizza, two hotdogs, and two cups of lemonade, we paid fifty bucks.
Obviously, those folks don't care what price they mark on things. They know
that people are buying it because it's there, convenient, and they'd have to
walk or drive too far to get anything else, so of course they're buying it.
We all gotta eat.  Huh? Just like all of us diabetics have to test our
blood.  Huh?
Bern

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