[Diabetes-talk] FW: Solo meter??

Tue Sep 3 18:46:56 UTC 2013

Here's the word from my contact at BioSense. He makes as much sense as any
meter manufacturer I've talked with. Please take advantage of his
information and offer.

Mike Freeman, President
Diabetes Action Network
National Federation of the blind

-----Original Message-----
From: Chris Gwaltney [mailto:chris at biosensemd.com] 
Sent: Tuesday, September 03, 2013 11:35 AM
To: 'Mike Freeman'
Subject: RE: [Diabetes-talk] Solo meter??

Mike,

Thank you for forwarding these messages to my attention.  There appears to
be several topics discussed in relation to accuracy, availability of
products, customer service, and the FDA.  I will do my best to respond to
all, but if I miss something please let me know.

BioSense takes all requirements by the FDA very seriously and strives to
exceed all expectations of documentation, reporting, and quality control.
Our protocols have been reviewed and cleared by the FDA as acceptable when
they visited our facility.  We have protocols in place to investigate,
document, and log any and all product complaints.  Those logs are reviewed
by multiple people on a daily basis to ensure all protocols are strictly
followed. 

In the messages below there appears to be far too much credit given to the
meter in the role of determining accuracy.  The meter has very little to do
with determining the accuracy of the test result.  The primary variable that
effects the accuracy of tests for a meter is the temperature of it's
environment.  All BG meters must adjust based on the temperature of its
environment, and this takes 20 - 30 minutes on average.  This is an often
overlooked, but very important factor in determining accuracy and
consistency.  It is also the only factor that a tester should be concerned
with, other than physical damage, in the meter's role of determining
accuracy.

Test strips, on the other hand, are much more sensitive.  Test strips can be
compromised by their environment if kept near the stove or shower - the
strips will absorb the moisture in steam.  Due to the tiny sample size
required strips can give false results if there is a tiny amount of moisture
that mixes in with that sample. The factors that can play into an abnormal
test result are far too numerous to list.  That is why we recommend that
testers call our customer service department if they experience questionable
results.  They will speak to a live person 24 hours a day who has been
trained to troubleshoot these types of issues.  While companies like ADS,
mentioned by Joyce, do their best to help, they lack the expertise on our
products that we have.  I can't speak to Prodigy's CS policies, but ours are
to troubleshoot and resolve the issue.  If we find the strips have been
compromised we replace them at no charge. The same is true for the meter and
control solution.  We only transfer callers to their product supplier when
they are requesting a refill.  Since those are not warranty calls we perform
a warm transfer to their product supplier. 

As far as the SOLO name change to SOLUS, it became necessary to only print
one name for manufacturing cost and planning purposes.  We chose SOLUS
because more product was distributed to more countries with that brand name
than SOLO.  Yes, we made some minor updates to the SOLUS meter.  Most of
those changes were done at the request of visually impaired and blind
community.  No changes were made to the base technology or functions of the
meter or strips.  The SOLO test strips were not changed,  only the name on
the box changed.

For those who expressed issues with the SOLUS meter or test strips, please
call our customer service team at 877.529.3922 so that we can get those
issues resolved ASAP.  I have complete confidence that the SOLUS V2
meters/strips are one of the most accurate products on the market.  I stand
behind our products 100% and will gladly make myself available to anyone who
would like to discuss these topics further. 

Thank you,
CG

Chris Gwaltney
Managing Partner
BioSense Medical Devices 
6555 Sugarloaf Pkwy Suite 307-168
Duluth, GA 30097
o 678.276.7075
f 888.620.2345
chris at biosensemd.com
www.BioSenseMD.com

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-----Original Message-----
From: Mike Freeman [mailto:k7uij at panix.com] 
Sent: Saturday, August 31, 2013 4:59 PM
To: Chris Gwaltney
Subject: FW: [Diabetes-talk] Solo meter??

Chris:

Can you comment on the message I'm forwarding you (content below) about the
Solus V2? The lady is not a member of our organization but is blind and is
on our list.

Also, I got a spam from an organization purporting to watch diabetes-related
stuff on the Net; I've attached it to this message. While the message is
spam, the FDA warning to Prodigy appears real enough even though it's
old-hat.

To the extent you are at liberty to say anything, what steps is BioSense
taking to fulfill the bureaucratic requirements FDA appears to be accusing
Prodigy of violating, e.g., implementing procedures to define all the
regulatory rigmarole as well as some of the violation reporting
requirements?

Thanks.

Mike Freeman

-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf Of
eileen scrivani
Sent: Saturday, August 31, 2013 10:41 AM
To: Diabetes Talk for the Blind
Subject: Re: [Diabetes-talk] Solo meter??

Cheryl:

I've had a lot of problems with the new Solus meter that I was upgraded to
back in March.  I've been using talking meters many many years as a blind
diabetic. In this case, brought the Solus V2 meter into my diabetes educator

to make sure I was applying the sample correctly.  I was.

Many times I test on this meter and get crazy numbers that would indicate
I'm ready to pass out and I'm not symptomatic at those readings.  Or I get
test after test or "TO LOW" or "No sufficient blood."  I'm not happy with
the Solus, but Loved, loved the Solo.

I've been told by other diabetics not to retest that the one resultthat
comes back should satisfy me, but I question the numbers I'm getting from
the Solus and intelligence tells me to re-check.  After all its my health
and my life that is at risk when I'm basing insulin dosages on these
numbers.

IMO only, something happened to the manufacturing process in the change of
either meter or strips from the Solo to the Solus and not many of us have a
personal one on one relationship with the owner of Advanced Diabetic
Solutions.  For that matter now ADS is done and gone out of the picture and
were left with no contact to help trouble shoot problems that come up. 
These big medicare approved providers are not giving product support and In
My Opinion that's a problem.

Eileen

-----Original Message-----
From: cheryl echevarria
Sent: Saturday, August 31, 2013 1:23 PM
To: Diabetes Talk for the Blind
Subject: Re: [Diabetes-talk] Solo meter??

I use Solo Meter with no problem, Greg Santulli of ADS, we see each other a
few times a year. Showed me how to take better tests. He said that after
lancing your finger, instead of trying to find the blood with the strip.
First make sure the strip is in the meter, than lance you finger, while
holding the meter in one hand hold the meter with the strip upside down
meaning, hold the meter with the strip out the bottom facing down. Sorry I
am bad at describing things.
and then touch the strip to the blood this will take some practice, but the
strip will suck in the blood that way, instead of it side ways.
Also a way of finding the blood again it will take practice, the blood will
be warm.
Dah moments here. Again, trying to explain what I am doing.
It has helped a lot getting more blood as well with smaller drops then
trying to pinch my fingers harder.
If you need more of an explanation, let me know.
Since he showed me how to do it, it is much better.
I like the solo meter much better than the prodigy, but some places it isn't

on there formulary to get the strips with Medicare.

Disabled Entrepreneur of the Year 2012 of NY StateLeading the Way in
Independent Travel!
Cheryl Echevarria,
Ownerhttp://www.echevarriatravel.com631-456-5394reservations@echevarriatrave
l.comhttp://www.echevarriatravel.wordpress.com

Affiliated as an independent contractor with Montrose TravelCST -
#1018299-10 FLST T156780Your old car keys can be the keys to literacy for a
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https://nfb.org/vehicledonations or call 855-659-9314.Echevarria Travel has
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braille needs.Gail Smith is the Secretary of the NFB of Alabama

> From: Blindhands at aol.com
> Date: Sat, 31 Aug 2013 13:00:13 -0400
> To: diabetes-talk at nfbnet.org
> Subject: [Diabetes-talk] Solo meter??
>
> Are folks having troubles similar to the Prodigy meter  with the  Solo 
> meter??  I have had these problems and if I feel things are not where  
> I think they should be I test over with blood from a different finger 
> and/or hand.
> I did not think of calling Prodigy.
>
> If you get the strips from where ever you get them, should you contact 
> Prodigy or the place you bought the strips from?
>
> Usually, I am not saying this has happen with Prodigy, but they send 
> you back to where you purchased it.  As in this letter, they replaced 
> the meter, but they did not replace the strips.  So they have you 
> running back  and forth and all you want is to know what your test 
> results are  correctly.
>
> Joyce  Kane
> _www.KraftersKorner.org_ (http://www.krafterskorner.org/) 
> Blindhands at AOL.com _______________________________________________
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> To unsubscribe, change your list options or get your account info for
> Diabetes-talk:
>
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otmail.com

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