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

Sat Aug 31 21:58:16 UTC 2013

Hi Mike,
I may not like it personally because I have problems getting enough blood. I do not care if it takes forty-five seconds or even 90 seconds to get a reading.
I do not even care if the meter has memory because I feel you can just make a list of readings.
If you do not know braille you can do it with a digital recorder.
My problem is the amount of blood which is my problem.
I would like to be able to successful test though.
Colleen Roth

----- Original Message -----
From: Mike Freeman <k7uij at panix.com>
To: "'Diabetes Talk for the Bl'" diabetes-talk at nfbnet.org
Date: Saturday, August 31, 2013 4:23 pm
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy Diabetes care

>
>
> Colleen:
> 
> You're not going to like what I'm going to say below. Part of the problem is
> that we're trying to get meters to require with less blood. From what I've
> seen, I am coming to the conclusion that we're going to have to tolerate a
> requirement of more, not less, blood to get a good analysis. Moreover, I
> read a paper a few years ago that pretty convincingly maintained that, given
> current microprocessor technology, one could not really even inind* an
> accurate analysis in five seconds and that if we wanted real accuracy, we'd
> have to go back to meters that take forty-five seconds to analyze what the
> strips tell them.
> 
> Mike Freeman
> 
> 
> -----Original Message-----
> From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
> COLLEEN ROTH
> Sent: Saturday, August 31, 2013 7:02 AM
> To: diabetes-talk at nfbnet.org
> Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy
> Diabetes care
> 
> Hi Mike,
> I hope we can get to the bottom of this. 
> I understand that there are some Talking Meters which require less blood on
> the strip.
> Since it is very hard for me or anyone else for that matter to get enough
> blood for a reading from me I would like to find a meter which needs less
> blood.
> If anyone knows of a Talking Meter which require less blood than the Prodigy
> Meter I purchased from NFB in 2011 that would be great.
> I mentioned where I got the Meter because I am not sure which one I have at
> the moment.
> Colleen Roth
> 
> ----- Original Message -----
> From: Mike Freeman <k7uij at panix.com>
> To: Diabetes Talk for the Blind diabetes-talk at nfbnet.org
> Date: Saturday, August 31, 2013 1:20 am
> Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy
> Diabetes 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.ht
> m#.Uhallyvg45gcaE.email
> > >> 
> > >> 
> > >> 
> > >> The Diabetes Watchdog
> > >> 
> > >> 
> > >> 
> > >> To visit our website click here: Diabetes Watchdog
> > > _______________________________________________
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