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

Thu Sep 5 19:02:08 UTC 2013

Hello Colleen, Bill Lewis here.

When I go to my doctor's office every four months for a A1C test and doctor 
exam, I notice that their lab has no trouble getting a blood sample from my 
finger, so I asked the nurse what size needle they use?

That was the magic question.  I find out that they simply have a larger 
diameter needle for their tester.  We can also request larger needles, as 
well.  It may require a different lancet, but that's okay.  If such a change 
makes a wider path through the tiny capularies in our fingers, all the 
better.  Try it and see.

-----Original Message----- 
From: COLLEEN ROTH
Sent: Saturday, August 31, 2013 4:58 PM
To: diabetes-talk at nfbnet.org
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued to 
ProdigyDiabetes care

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
> > > _______________________________________________
> > > Diabetes-talk mailing list
> > > Diabetes-talk at nfbnet.org
> > > http://nfbnet.org/mailman/listinfo/diabetes-talk_nfbnet.org
> > > To unsubscribe, change your list options or get your account info for
> Diabetes-talk:
> > >
> http://nfbnet.org/mailman/options/diabetes-talk_nfbnet.org/k7uij%40panix.com
> >
> > _______________________________________________
> > Diabetes-talk mailing list
> > Diabetes-talk at nfbnet.org
> > http://nfbnet.org/mailman/listinfo/diabetes-talk_nfbnet.org
> > To unsubscribe, change your list options or get your account info for
> Diabetes-talk:
> > http://nfbnet.org/mailman/options/diabetes-talk_nfbnet.org/n8tnv%40att.net
>
> _______________________________________________
> Diabetes-talk mailing list
> Diabetes-talk at nfbnet.org
> http://nfbnet.org/mailman/listinfo/diabetes-talk_nfbnet.org
> To unsubscribe, change your list options or get your account info for
> Diabetes-talk:
> http://nfbnet.org/mailman/options/diabetes-talk_nfbnet.org/k7uij%40panix.com
>
>
> _______________________________________________
> Diabetes-talk mailing list
> Diabetes-talk at nfbnet.org
> http://nfbnet.org/mailman/listinfo/diabetes-talk_nfbnet.org
> To unsubscribe, change your list options or get your account info for 
> Diabetes-talk:
> http://nfbnet.org/mailman/options/diabetes-talk_nfbnet.org/n8tnv%40att.net

_______________________________________________
Diabetes-talk mailing list
Diabetes-talk at nfbnet.org
http://nfbnet.org/mailman/listinfo/diabetes-talk_nfbnet.org
To unsubscribe, change your list options or get your account info for 
Diabetes-talk:
http://nfbnet.org/mailman/options/diabetes-talk_nfbnet.org/wlewis19%40cox.net 