FDA Safety Warning Freestyle, Accu-Chek Test Strips

[O'Riley]

I was on the Bayer website this evening and saw this statement: "Bayer's Contour and Bayer's Breeze2 Blood Glucose Monitoring Systems Do Not Use the Problematic GDH-PQQ Technology." Naturally, my first thought was, "Is my meter using a problematic technology?" This is what I found:

Blood glucose meters with strips that use a technology called GDH-PQQ can lead to insulin overdose under certain circumstances, and should not be used by insulin-using diabetics who are using interfering products. GDH-PQQ test strips are not "glucose specific", so they also react to other sugars.

FDA Warning:
http://www.fda.gov/MedicalDevices/Sa.../ucm177189.htm

FDA List of Affected Test Strips:
http://www.fda.gov/MedicalDevices/Sa...htm#attachment

FDA Public Health Bulletin:
http://www.fda.gov/MedicalDevices/Sa.../ucm176992.htm

Article in Endocrine Today which describes the problem:
http://www.endocrinetoday.com/view.aspx?rid=62860

Another article:
http://www.aboutlawsuits.com/fda-war...t-strips-5415/

Are there drugs that we're using on our dogs that would be considered "interfering prouducts"? Would glucosamine fall into this category?

[CarolW]

Re: FDA Safety Warning Freestyle, Accu-Chek Test Strips

Very interesting, O'Riley. You are quite the researcher! I don't have time to follow up right now, as I spent much of today PLAYING! (first time in some time!)

Thanks for the links!

Fri, 30 Apr 2010 22:37:48 (PDT)

[Taylor]

Re: FDA Safety Warning Freestyle, Accu-Chek Test Strips

Excellent research. I have been looking at methyl B-12 to help with neuropathy but have been unable to find any that does not contain other sugars. Looks like something like that could throw off results with the subject strips. Pat

[Patty]

Re: FDA Safety Warning Freestyle, Accu-Chek Test Strips

Rosey,
That's good research. I think I'd heard this before and had forgotten about it. Luckily most of what our dogs are exposed to don't contain non-glucose sugars as products like xylitol are toxic. But as it says certain drugs may contain non-glucose products or be metabolized into them. It's worth finding out what's in the medications we give and how they may interact with testing.

Here's some exerpts for those that don't have time to follow the links.
Patty

Nature of the problem

GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product.
When these non-glucose sugars are present in the patient’s blood, using a GDH-PQQ glucose test strip will produce an elevated glucose result which may suggest the need for clinical action. This can lead to inappropriate dosing and administration of insulin, potentially resulting in hypoglycemia, coma, or death.
In addition, cases of actual hypoglycemia may go unrecognized if the patient and healthcare practitioner rely solely on the test result obtained with the GDH-PQQ glucose test strips.
http://www.fda.gov/MedicalDevices/Sa.../ucm176992.htm

List of GDH-PQQ Glucose Test Strips

The following test strips (with associated meters) use GDH-PQQ methodology as of August 2009:
Roche Diagnostics:

1. ACCU-CHEK Comfort Curve test strips, for use with:
   • ACCU-CHEK Inform meters [model 2001201]
   • ACCU-CHEK Complete meters [models 200 and 250]
   • ACCU-CHEK Advantage meters [models 888, 831, 850, and 768]
   • ACCU-CHEK Voicemate meters [model 0009221]
2. ACCU-CHEK Aviva test strips, for use with:
   • ACCU-CHEK Aviva meters [models 525, 535, and 555]
3. ACCU-CHEK Compact test strips, for use with:
   • ACCU-CHEK Compact meters [model GF]
   • ACCU-CHEK Compact Plus meters [models GP and GT]
4. ACCU-CHEK Go test strips
   • ACCU-CHEK Go meters [model GJ]
5. ACCU-CHEK Active test strips
   • ACCU-CHEK Active meters [models GG and GN]

Abbott Diabetes Care:

1. Freestyle test strips, for use with:
   • FreeStyle meters
   • FreeStyle Flash meters
   • FreeStyle Freedom meters
2. Freestyle Lite test strips, for use with:
   • FreeStyle Lite meters
   • FreeStyle Freedom Lite meters

Home Diagnostics:

1. TRUEtest test strips
   • TRUEresult meters
   • TRUE2go meters

Smiths Medical:

1. Abbott Diabetes Care Freestyle test strips, for use with:
   • CoZmonitor blood glucose module (for use with the Deltec Cozmo Insulin Pump)

Insulet:

1. Abbott Diabetes Care Freestyle test strips, for use with:
   • OmniPod Insulin Management System

http://www.fda.gov/MedicalDevices/Sa.../ucm176992.htm

[ozzi]

Re: FDA Safety Warning Freestyle, Accu-Chek Test Strips

That is an interesting question about using strips and their associated meters that utilize the GDH-PQQ technology in a dog who is taking glucosamine. From my organic chemistry days, glucose has a molecular structure of C6H12O6 and glucosamine is an amino sugar with a similar structure: C6H13NO5. According to wikipedia, glucosamine is a prominent precursor in the biochemical synthesis of glycosylated proteins and lipids. So, it may be possible that glucosamine is one of the non-glucose sugars that could affect the GDH-PQQ test strips. I would definitely check with your vet about that. The good thing is that the false high result is rare, but still, it would be good to know since none of us wants to take any chances with our dogs!!
Kevin

[O'Riley]

Re: FDA Safety Warning Freestyle, Accu-Chek Test Strips

Patty….thank you for providing more details right here within the thread – makes it a lot easier to discuss without having to follow links.

This could be serious for our pets, and it’s alarming to me that the veterinary community apparently wasn’t targeted as part of the FDA’s notification. There have been human deaths because of these test strips and our pets are no less vulnerable. Could pets be even more at risk because of their small size relative to the human body which gives them less of an ability to recover from an insulin overdose == less margin of error, less wiggle room?

Freestyle is one of the culprit strips which should have also made Alpha Trak test strips part of the FDA public health warning. We’re a phantom group of consumers that these companies don’t mind making a buck off of, but just try getting help from one of their tech reps when you mention that you’re really treating diabetic Fido.

Kevin, I envy your organic chemistry knowledge. About the false highs, are they really that rare? Riley can go from 110 to 480 any day of the week. I couldn’t even begin to analyze all of the ingredients in the vitamins and supplements I’m giving Riley. For example, does aloe vera at some point convert to a non-glucose sugar? Do any of the dozens of botanicals contained in the PhD “Wellness” that I put on his food convert to sugars? Since Riley’s glucose readings are all over the place, I wouldn’t know how to differentiate between a false reading and a real one. Whether there have been pet deaths because of the strips, who can say? But if I'm trying to arrive at a safe dose of insulin for my dog, how can I begin to factor in a major test strip problem on top of everything else? It’s safer and easier for me to permanently retire my Alpha Trak and Freestyle meters, and use a non-GDH-PQQ-based meter.

Pages 4 & 5 of this document contains photos of meters and their test strips, and which test strip technology they use:
http://www.tricare.mil/pharmacy/bap/...ut%20final.pdf

Page 2 of this document (look on right side of page 2), lists other reagent problems. Apparently GDH-PQQ is not alone in causing errors. So which test strip is least problematic?
http://www.rxfiles.ca/rxfiles/upload...betes-SMBG.pdf

[ozzi]

Re: FDA Safety Warning Freestyle, Accu-Chek Test Strips

About the false highs, are they really that rare?

That's a good point! I got that information from one of the links you provided, but who's to say how rare or not it is in dogs. I know that the human meters are made to test human red blood cells, which differ from canine red blood cells, which is why the readings are generally lower than the actual reading. This is a good thing from the perspective of hypoglycemic events in that we can intervene on a low meter reading before it actually reaches that number. I think most meters run about 30-60 points lower than the actual reading if you were to have your dog's blood tested at a lab. The flip side of that is a "false high" from the strips you mention would therefore indicate an even higher BG in your dog than the reading you see on your meter. So I can see where it would really potentially complicate managing a dog's diabetes.

It’s safer and easier for me to permanently retire my Alpha Trak and Freestyle meters, and use a non-GDH-PQQ-based meter.

It would be interesting to try a different meter with strips that utilize a non-GDH-PQQ technology, and compare the results with what you are getting now. It might give you the answer! If you still get the same fluctuations, then it would indicate something else is going on. I would definitely give it a try with a Bayer Contour or some other meter that doesn't use that specific technology. I happen to use a Bayer Contour and I'm happy with the ease of use, since it does not require coding. If you do try a different meter, I would definitely be interested in the results you get as compared to what you are currently seeing for BG values.
Kevin

[O'Riley]

Re: FDA Safety Warning Freestyle, Accu-Chek Test Strips

Kevin....I have the following meters and have noted the test strip technology used by each:

AccuChek Aviva: GDH-PQQ
Freestyle Lite: GDH-PQQ
OneTouch Ultra Mini: Glucose Oxidase (GOD)
ReliOn Confirm: Glucose Oxidase (GOD)

That's a good idea -- to do a side-by-side test. Every time I get a new meter, I do a mini test comparison with my favorite meter (ReliOn Confirm). The ReliOn readings are always higher by about 25 points when compared to the other meters when Riley is reading in the lower range; and about a 38-40 point higher difference in the higher ranges. This isn't a scientific comparison, just done to satisfy my own curiosity. Funny thing is, since the other meters alway read lower, I've been thinking I have to make allowances for the Reli-On meter. You're saying that meters read dog BG levels lower than they really are. So it sounds like there's a possibility that my ReliOn is reading closer to the true reading. Hmmm. Could it be that the cheapest and easiest to use meter, with the lowest upkeep (least expensive test strips), is really the best dog meter? I don't know. I do know that the tiny droplet I get from Riley's ear gives me a reading every time, and not even the Freestyle has been able to do that.

According to the chart on the link I posted previously:
http://www.rxfiles.ca/rxfiles/upload...betes-SMBG.pdf

....the test strip technology used by the ReliOn Confirm (also used by the OneTouch Ultra Mini), should be reliable as long as Riley doesn't take up scuba diving.

I should add that ReliOn's Confirm has three control solutions, (low, normal and high) that you can use to test the strips. I don't know if the other's do or not, but ReliOn's Customer Service is the only one that has sent me all three solutions.