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

Mon Sep 2 21:07:14 UTC 2013

Amen, Sandy! 
Frankly, I think the FDA needs to go after most meter companies while
they're at it. I too could not get the Prodigy to work for me, as too many
of my numbers were way off because of not enough blood. It's amazing to me
to think that if one gets a continuous glucose monitor, it must be
calibrated to the BG meter. Really? Unbelievable! 
And yes, a separate speech box would still have to be tested by the FDA with
the particular meter. The advantage for the manufacturers is that a third
party could actually manufacture the box and the meter makers wouldn't have
to retool their factories or make different meters. For this reason, it
might speed up the process and give us quicker access to more mainstream
devices. And I'll try not to get off on my rant about insurance companies.
But hey, sometimes life has to be about more than just cheap. Can't wait for
the first successful law suit against an insurance company for providing
inferior care just to make a profit. Okay, off my soap box now. <grin> But
there are things that I think could be done. Give insentives for Prodigy to
clean up their act, if that would help. Right now it seems that our society
sure knows how to ban things, punish companies, but not how to work together
and really make something work. This would sure be a great time to break
that cycle in my opinion.
Veronica

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-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
Sandi Ryan
Sent: Saturday, August 31, 2013 9:45 AM
To: Diabetes Talk for the Blind
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to
ProdigyDiabetes care

Sorry, but it's true.  Having read through the FDA letter, I have no doubt 
whatsoever that this is a real issue, and I have personally experienced 
issues like these with the Prodigy Voice meter.  I have not reported them.

This seems like an issue we must address as a division of NFB, officially! 
It's appalling that in the treatment of diabetes, so many of the devices and

accompanying items are inaccessible or sort of accessible.  Why is it more 
important for an eReader to be completely accessible than a product or 
device that can save or threaten a life?  I believe that not only the DAN, 
but also the whole of NFB needs to be aware of this issue and to speak out 
on it!

Sandi

----- Original Message ----- 
From: "Mike Freeman" <k7uij at panix.com>
To: "Diabetes Talk for the Blind" <diabetes-talk at nfbnet.org>
Sent: Saturday, August 31, 2013 12:17 AM
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to 
ProdigyDiabetes 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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