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  

Trying out lower carb living

At the recent diabetes care summit, I was fortunate to share a ride from the airport with a great diabetes blogger, David Mendosa.

David has type 2 diabetes. and one of the things we talked about was low carb diets and the benefits of using them. I know I'm not alone in this, but I have a terrible time controlling my cravings for carbohydrates. David told me that it had taken him about 2 weeks to get over the desire for carbs. And he can talk about the benefits, including better blood sugar control and weight loss.

Despite my Dexcom and insulin pump, I still have too many days where the curves look like the ocean on a stormy day. This week I decided to experiment a little with changing what and how I eat. For the last 3 days I've been avoiding excess carbs and eating more vegetables, protein and fiber.

And the results? See for yourself.
The green area represents readings between 80 mg/dL and 140 mg/dL. And I'm spending a lot of time in that range.

What have I learned so far?

First of all I can live with fewer carbs and it makes a huge difference to my blood glucose control. And with some thinking I can still exercise and maintain a semblance of control. Part of those 2 days included two 14-mile bike rides and my levels were reasonable for most of those.

I also know that 3 days does not make for a really changed relationship with food. Tomorrow I'm going to borrow Dr. Bernstein's book Diabetes Solution: The Complete Guide to Achieving Normal Blood Sugars. And I'm going to checkout whether I can take some of his approach and use it for my life with type 1.

Have you tried a lower-carb diet? What challenges did you have and did you figure out a way to deal with them? I'd love any help you can offer.

Update 10/26: I just got my A1C and the number was (drum roll) 6.8%. This is a great number, but not really as good as I was hoping and expecting. Mostly I've managed to stay away from snacking and over doing the carbs. Some days are better than others. The biggest problem I've found? Getting a good set of low carb recipes to replace all the old recipes I already have.

Labels: bernstein, blood sugar, carbs, control, lowcarb

posted by Bernard @ 10:29 PM 15 Comments Links to this post  

More on the Medingo Solo

I blogged last week about the approval of the Medingo Solo insulin pump by the FDA. This week Medingo is showing it at the AADE conference and they've finally unveiled more details at the Medingo Solo website solo4you.com.

While the technical specifications are not available, they do have this video that shows some of the features.


The PDA part (Solo Remote) comes with different colored skins.

There are four parts to the Solo pump itself: Solo Remote; Reservoir; Pump Base; and Cradle.


The pump base is described as a '3-month insulin Pump Base that stores all your pump parameters'. Medingo says it last 90 days. Medingo provides you with a spare pump base, which will make replacement much less of a problem.

The reservoir holds up to 200 units of insulin and has a single mercury-free battery (grey circle to the upper right of the picture above). So each time you change the reservoir you get a new battery, it's not clear how recyclable it is. The cradle is the part that's attached to you, it's got the cannula. According to the site, a bad insertion can be fixed by just replace the cradle without losing much insulin. Changing the 'set' means replacing the reservoir and cradle. It's not clear how waterproof the base/reservoir are, so you need to detach these if you're swimming.

The Solo Remote has a color screen. It downloads settings to the pump base so that it will operate to some degree without the remote. The pump base has buttons (highlighted in orange in the picture) that allow bolusing without the remote. I assume this is like other pumps where you set a predetermined bolus amount and press a certain number of times to get a bolus of a certain size.

The Solo website does have a page to sign up for "Size Up Solo" demo kit. I've already done this, just be aware that the address entry fields are front to back and you'll be all set.

I'll update this post as I learn more. There are no posted specifications for the Medingo Solo system that I can find, from the video it looks very slim but I'll suspend judgment until I can get a copy of the user manual.

From what I've seen online, this looks like an improvement in usability and design over other pumps. I think we're going to see more of these insulin patch pumps over the next few years.

Labels: design, innovative, insulin, insulin pump, medingo, Solo

posted by Bernard @ 7:07 PM 15 Comments Links to this post