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

Sat Aug 31 19:58:58 UTC 2013

I agree the eReader is an important issue.  I'm not trying to play "We're 
more important" here--but I don't think the eReader is more important.

I've done all those things too, and I hate, hate, hate checking my blood 
sugar, because it's always a hassle to get blood, and I've learned not to 
trust my Prodigy!

Sandi

----- Original Message ----- 
From: "COLLEEN ROTH" <n8tnv at att.net>
To: <diabetes-talk at nfbnet.org>
Sent: Saturday, August 31, 2013 1:55 PM
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued 
toProdigyDiabetes care

> Hi Sandi,
> I think many people didn't know about this issue until today. Like you, 
> many people probably didn't report their issues.
> I have had so many times when my meter wouldn't or couldn't read from the 
> blood on my test strip. This is true even when a sighted friend of mine 
> who is a nurse has used my meter to do the test for me.
> Sometimes she thinks I should have enough blood and it still doesn't work.
> I just figured it was me.
> Of course it still could be me.
> The E-reader is important for those who are going to school in particular.
> This problem with the Prodigy Meters is also pretty important.
> I have wondered what would happen to someone who just can't get enough 
> blood on the strip.
> Yes I have run my hands under hot water, rubbed them, put something around 
> the finger I want to poke, put the lancet at the highest number, let my 
> hand hang down, and literally pushed my finger as hard as possible toward 
> the lancet.
> I have even poked my poor finger with the lancet, new each time) several 
> times to no avail.
> I have even tried poking my arm.
> This could be a real problem for someone who is not a very well controlled 
> Diabetic.
> I guess we will find out more after the Holiday.
> Colleen Roth
>
>
>
> ----- Original Message -----
> From: Sandi Ryan <sjryan2 at gmail.com>
> To: "Diabetes Talk for the Blind" diabetes-talk at nfbnet.org
> Date: Saturday, August 31, 2013 12:45 pm
> 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.htm#.UhYvg45gcaE.email
>> >>>
>> >>>
>> >>>
>> >>> The Diabetes Watchdog
>> >>>
>> >>>
>> >>>
>> >>> To visit our website click here: Diabetes Watchdog
>> >> _______________________________________________
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>> >
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>>
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