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

Sat Aug 31 18:55:16 UTC 2013

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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