FDA warning - fatal errors with some glucose test strips

I received a public health notification this afternoon from the FDA. You may get high blood glucose test results if you're using test strips based on GDH-PQQ and you're taking medication that contains non-glucose sugars. Note: this is not a recall, it's a warning.

The partial list of medications includes:

• Extraneal (icodextrin) peritoneal dialysis solution
  
• Some Immunoglobulins: Octagam 5%, Gamimune N 5% (no longer distributed in US), WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous(Human), and HepaGamB
  
• Orencia (abatacept)
  
• Adept adhesion reduction solution (4% icodextrin)
  
• BEXXAR radioimmunotherapy agent
  
• Any product containing, or metabolized into maltose, galactose or xylose. (Usually over the counter products)

The FDA has provided a list of test strips affected by this warning. These include: many Accu-chek products; Abbott FreeStyle strips, including those for the Cozmo and Omnipod insulin pumps; and TRUEtest strips.

If you're affected by this warning and you encounter a false high reading, you can report issues directly to the FDA.

If you're not affected by this warning, it's a good reminder to wash your hands before testing. It's way too easy to get a false high reading because of foodstuff on your fingertips.

You can subscribe to these kinds of warnings but very few of them are related to diabetes devices, just fill out the simple form on this FDA subscription page.

Update: I received several press releases on this issue from various manufacturers of blood glucose test strips. Assuming it's reasonably accurate, the most useful is this document (PDF) from Roche Diagnostics. Table 2 below (click to see it in a readable size) lists some of the drugs that can cause maltose interference, about how many people are using them, and how they're delivered. Most of these drugs are used in hospital settings. From this table it seems like Extraneal users is the group most likely to have people with diabetes, and I'm assuming hospitals have been notified.

Bayer has posted a press release to say that their products are not affected by this warning. I spoke with someone from Agamatrix (makers of WaveSense meters) and their strips are also not affected by this warning as they use glucose oxidase.

Labels: Abbott, Accu-Chek, FDA, health, notification, testing, warning

posted by Bernard @ 5:10 PM 0 Comments Links to this post  

An effusion of testing

At 4 PM EST today, a lot of folks were testing their blood sugar readings. Paraphrasing Kerri, you could almost hear the collective shunk of our lancets.

Anyone with diabetes tests their blood sugar from time to time. If you've got type 1 diabetes you probably test at least five times daily. After a very short while you get used to it, it's just part of the wearing routine that's living with diabetes.

But today it felt very different because of a great idea from Kelly Rawlings. What if we tried to get a lot of people to test and post the results online at the same time.

How many people? 14,000 -- it's a good target number because sometime soon there will be 10,000 members in TuDiabetes.com, one of the best diabetes online communities. And EsTuDiabetes.com, the Spanish language version, has about 4,000 members. So all we needed was for each of those members to test and post.

Watching the Twitter feed at 3 PM today surprised me. There were hundreds of tweets all marked with the #14kPWD hash tag as people counted down to the test time. Folks were giving pointers to time clocks for folks in other parts of the world.

I have never seen so many people who were giddy about testing. People were posting test results in advance to see if they could get their number to a reasonable level. Some of us were wondering how many people would hit the magic 104 number. (That's the reading shown of the box of many blood glucose meters and a number that few of us see during the course of a week or even month.) Others were counting down to 4 PM, the official test time.

Was it effective at raising diabetes awareness? I can't say...yet.

But we did have A Parade of Test Strips and speaking for myself it was a lot of fun. In the end about 700 results were posted. I'll bet that for some of those posting it was the first time they'd shared a BG reading with anyone.

Thanks for pulling this together everyone in the diabetesoc and here's to the next wacky event that makes living with diabetes a little more of a community thing.

Labels: 14kpwd, diabetes, events, testing

posted by Bernard @ 9:21 PM 2 Comments Links to this post