[Diabetes-talk] Fwd: FDA Warning Letter Issued to ProdigyDiabetes care
n8tnv at att.net
Sat Aug 31 18:55:16 UTC 2013
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.
----- 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!
> ----- 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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