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

[Sandi Ryan]

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.htm#.UhYvg45gcaE.email
>>>
>>>
>>>
>>> The Diabetes Watchdog
>>>
>>>
>>>
>>> To visit our website click here: Diabetes Watchdog
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