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

Sat Aug 31 20:41:52 UTC 2013

Sandi:

Lauren McClarney and I are working on effective responses to issues such as
this and some of the problems with Medicare. I'm going to be brutally honest
here and I'm sure some won't like it. But I owe you and the members of DAN
nothing less.

First, there are a lot more NFB members who use e-book-readers or
potentially would use them than DAN members. This sounds awful but, as Tom
Lehrer once said, "you can't have opinions about Truth". I think most NFB
members think DAN is successfully handling all issues involving blind
diabetics and are content to have it so. Conclusion: we aren't going to get
much of a ground-swell within NFB to petition agencies to change things. I'm
sure it is so within ACBDA also.

Second, even if we could, what would we do immediately? After all, the
e-reader business is trying to influence regulations implementing a law
already on the books. Hard as this may be to imagine, there really are no
laws on the books that help us much. Oh yes; the Access Board was inquiring
about regulations dealing with *physical* access to medical equipment (can a
person in a wheelchair use a mammogram machine, for example) but there
aren't really laws on the books mandating access by the blind and visually
impaired to medical equipment such as insulin pumps, glucose meters and the
like. The closest we've come is our Technology Bil of Rights and our Home
Appliance Accessibility Act. And you know just about how far those have
gotten. I know some will accuse me of being partisan. I am not; I am talking
facts here. I submit that passage of the Technology Bill of Rights or the
Home Appliance Accessibility Act is highly unlikely in an atmosphere wherein
a substantial portion of the House of Representatives abhors mandates upon
business and may be willing to shut down the government to get rid of
Obamacare without replacing it with anything.

This leaves us, as I see it, with only perhaps two alternatives: (a) we can
advocate that all glucose meters and insulin pumps be made accessible -- a
nonstarter as I've shown above, or (b) going state-by-state and seeking
passage of legislation that (a) requires all equipment to be accessible
and/or (b) mandates that all insurance carriers pay for accessible diabetes
devices and ancillary equipment (strips, control solution, etc.). One could
interpret this, in light of the Prodigy warning, to even include putting
Braille and large-print lot numbers on boxes of strips and control solution.

Either way, we'd have much work to do. And I'm open to other suggestions
that take account of political reality. In other words, I want ideas that
don't mandate that NFB implement Heaven on earth; were this to happen, we
wouldn't need NFB! (huge grin)

Mike Freeman

-----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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