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

Thu Sep 5 18:38:58 UTC 2013

I kind of suspected something like this as I've seen similar warnings from
the FDA to insulin pump companies. Glad everyone seems to be on top of
things though. It shows people are doing their jobs, which is what we want.
Veronica

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-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
Kelly Massaro
Sent: Thursday, September 05, 2013 6:41 AM
To: 'Diabetes Talk for the Blind'
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued
toProdigyDiabetes care

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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>> >> 0panix.com
>> >
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>>
>>
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