- A large paper alert insert is now found inside new boxes of
"Accu-Chek Comfort Curve test strips." This product is currently
on shelves in pharmacies everywhere:
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- Below is an exact copy of the above product alert,
exactly word for word to insure clarity:
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- URGENT!
- Important!
- NEW INFORMATION!
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- ACCU-CHEK Advantage and ACCU-CHEK Voicemate blood glucose
meter users
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- Please read important new information in the gray box
of the enclosed test strip package insert
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- Roche Diagnostics has indentified a situation that occur
no more once every seven days, during a ten-minute time period, which can
cause an individual test result to be stored incorrectly in the memory
of the ACCU-CHEK Advantage meter and spoken incorrectly by the voice module
of the ACCU-CHEK Voicemate system. The result on the display of the ACCU-CHEK
Advantage meter at the time of testing is not affected.
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- The unique situation does not occur with the ACCU-CHEK
Complete, AccuData GTS Plus/GTS, ACCU-CHEK HQ, and ACCU-CHEK Inform blood
glucose monitoring systems. Roche Diagnostics is committed to providing
you with quality products and services. If you have any questions or need
assistance, you can reach us 24 hours a day, 365 days a year at 1-800-858-8072.
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- THIS IS AN EXTREMELY SERIOUS PROBLEM
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- For those not familiar with the daily life of those
with diabetes, daily measurement of blood glucose (sugar) levels is very
critical to proper management of the disease. Those with diabetes are taught
to regulate their insulin levels based on the readings they depend on from
their personal glucose meters.
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- Now imagine the problem of the vision impaired, that
DEPEND on voice-generated test results to adjust their insulin levels.
If they increase their insulin based on a false high reading of blood sugar
from their meter, they could go into insulin shock. Now imagine what happens
to that person if someone isn't around when this happens to call 911.
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- Glucose meters today use built-in processors that depend
on permanent software. In engineering this is known as "firmware"
because it cannot be changed. Diabetics that purchase these meters depend
on some unknown programmer (with an unknown competence level) for
their very lives. Just how bad is Roche's quality control and
assurance program, such that defective products like this are shipped to
millions of people? Because of the arrogance of Roche they don't even provide
details about WHEN this "error" happens. Diabetics looking through
the stored readings in their meters won't even know which readings are
wrong.
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- There is absolutely NO EXCUSE for this kind of software
bug to happen. If you know a diabetic using a talking glucose meter covered
in the above notice, make sure they stop using that meter now and obtain
a new meter to use. Then contact Roche immediately for possible replacement
or compensation.
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- So what do we hear about this serious problem in the
media? Not one word.
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- And what if there is a bug in the anti-skid braking module
firmware of your vehicle you that we all depend on when driving during
heavy rain, ice or snow? Will we also be told about bugs like this too?
I've written essays about firmware problems before. If you buy a bathroom
scale (which the digital scales also have processors) and it doesn't work
quite right, it's not a serious problem.
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- But for this problem to occur in an important
medical instrument for life-saving diabetes treatment must be considered
a VERY SERIOUS PROBLEM.
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- Ted Twietmeyer
- www.data4science.net
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