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

Thu Sep 5 13:40:59 UTC 2013

To NFB members and valued Prodigy patients and partners,  

I apologize for the delay in responding to this post, however I have
attached Prodigy's response to the FDA warning letter you reference.

If you have any questions, don't hesitate to contact me.

Kelly Massaro
kellym at prodigymeter.com
704-458-9400

-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
Sandi Ryan
Sent: Saturday, August 31, 2013 3:59 PM
To: Diabetes Talk for the Blind
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued
toProdigyDiabetes care

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/u
>> >>> cm360148.htm#.UhYvg45gcaE.email
>> >>>
>> >>>
>> >>>
>> >>> The Diabetes Watchdog
>> >>>
>> >>>
>> >>>
>> >>> To visit our website click here: Diabetes Watchdog
>> >> _______________________________________________
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>> >> http://nfbnet.org/mailman/options/diabetes-talk_nfbnet.org/k7uij%4
>> >> 0panix.com
>> >
>> > _______________________________________________
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>> >
>>
>>
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