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

Mon Sep 2 21:23:17 UTC 2013

Mike and others,
Well, this five-second test always did puzzle me a bit. I don't know about
the rest of you, but often, when I finally get enough blood, I haven't
stopped the bleeding in five seconds. So I couldn't respond to the result
anyway. This one has always sounded like marketing getting in the way of
product design.
And the second thing I don't understand, I'm still using my FreeStyle Lite
meter. It doesn't start the test until it decides that it has enough blood.
This contrasts with most meters that start the test when any blood hits the
sensor, assuming that more blood will be added in time. If more meters
behaved as the FreeStyle does, we would have fewer not enough bloods and
wrong numbers. I would think that this would make sense for everyone, not
just us. 
So for now, I'm sticking with my FreeStyle. Now I have to take my old
Braille 'n speak down to batteries plus because it's no longer portable. But
boy what I wouldn't give for a functioning third party box for this meter.
Having said all of that, I've seen strange picky warnings go out from the
FDA to various pump companies as well. I don't honestly know what makes them
decide to pounce when and where they do, and ignore when they do that.
In the meantime, thank you, major thank you to those of you who are doing
serious investigations on our behalf. I sure appreciate it.
Veronica

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-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
Mike Freeman
Sent: Saturday, August 31, 2013 1:21 PM
To: 'Diabetes Talk for the Blind'
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy
Diabetes care

Colleen:

You're not going to like what I'm going to say below. Part of the problem is
that we're trying to get meters to require with less blood. From what I've
seen, I am coming to the conclusion that we're going to have to tolerate a
requirement of more, not less, blood to get a good analysis. Moreover, I
read a paper a few years ago that pretty convincingly maintained that, given
current microprocessor technology, one could not really even *do* an
accurate analysis in five seconds and that if we wanted real accuracy, we'd
have to go back to meters that take forty-five seconds to analyze what the
strips tell them.

Mike Freeman

-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
COLLEEN ROTH
Sent: Saturday, August 31, 2013 7:02 AM
To: diabetes-talk at nfbnet.org
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy
Diabetes care

Hi Mike,
I hope we can get to the bottom of this. 
I understand that there are some Talking Meters which require less blood on
the strip.
Since it is very hard for me or anyone else for that matter to get enough
blood for a reading from me I would like to find a meter which needs less
blood.
If anyone knows of a Talking Meter which require less blood than the Prodigy
Meter I purchased from NFB in 2011 that would be great.
I mentioned where I got the Meter because I am not sure which one I have at
the moment.
Colleen Roth

----- Original Message -----
From: Mike Freeman <k7uij at panix.com>
To: Diabetes Talk for the Blind diabetes-talk at nfbnet.org
Date: Saturday, August 31, 2013 1:20 am
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy
Diabetes care

>
>
> I'm going to research this a bit before endorsing this to see that it is
not a bit of industrial sabotage or mischief. I got a copy also and,
frankly, I'm a bit cautious. If the warning pans out, however, we may have
to put our collective thinking caps on to figure out how to proceed as the
Solus V2 isn't on the formulary of many insurance carriers yet. 
> Mike freeman 
> 
> On Aug 30, 2013, at 19:52, Vincent Chaney Jr <vgc732 at optonline.net> wrote:
> 
> > Greetings to All:
> > 
> > FYI...
> > 
> > This FDA information and the link to the letter are an interesting read.
> > This may be something to consider if in the plans to buy a meter
> > 
> > Vincent
> > President DAN of New Jersey
> > 
> > 
> > 
> > Sent from my iPhone
> > 
> > Begin forwarded message:
> > 
> >> From: watchdog at diabeteswatchdog.org
> >> Date: August 30, 2013, 4:46:16 PM EDT
> >> To: vgc732 at optonline.net
> >> Subject: FDA Warning Letter Issued to Prodigy Diabetes care
> >> 
> >> The US Food and Drug Administration (FDA) published a written warning
letter to Prodigy Diabetes Care identifying serious violations for the
Prodigy Blood Glucose Test System, Prodigy Voice Blood Glucose Monitoring
System, Prodigy Autocode Blood Glucose Meter, and Prodigy Pocket devices.
FDA inspected Prodigy facilities and cited numerous violations and
complaints that were not properly reported and that "reasonably suggests
that Prodigy's device may have caused or contributed to a life threatening
injury".  The letter goes onto detail failures in Prodigy's manufacturing
processes, quality control processes, record keeping, and details test strip
lots that were distributed by the company despite failing to meet accuracy
standards. 
> >> 
> >> The letter can be read in its entirety on the FDA website:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm360148.ht
m#.UhYvg45gcaE.email
> >> 
> >> 
> >> 
> >> The Diabetes Watchdog
> >> 
> >> 
> >> 
> >> To visit our website click here: Diabetes Watchdog
> > _______________________________________________
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> 
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