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

Fri Sep 6 23:22:12 UTC 2013

Hello, does adjusting the number your lancet device is set on help you? I 
can set mine any where from one to six. Mostly I can use mine set on one if 
I am not sick, and also using a particular area and finger for the stick. I 
have terrible luck with the thumb, and best results on my little finger. I 
do use all fingers  excluding my Braille fingers.

Debbie
----- Original Message ----- 
From: "Bill Lewis" <wlewis19 at cox.net>
To: "Diabetes Talk for the Blind" <diabetes-talk at nfbnet.org>
Sent: Thursday, September 05, 2013 2:02 PM
Subject: Re: [Diabetes-talk] Fwd: FDA Warning Letter Issued 
toProdigyDiabetes care

>
> 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
>> > > _______________________________________________
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>> >
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