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.
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 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.
Today Abbott reported that the FDA has (finally) approved the FreeStyle Navigator continuous glucose monitor(CGM) for sale in the US.
This is one of the most anticipated CGM devices. Many people I've spoken with have expected that this CGM will solve all the shortcomings of the Dexcom and Minimed devices. I've also talked with several people who have been using the Navigator. My take is that this is no more perfect that the existing CGM alternatives.
Abbott, who even has a special site for the Navigator, says that it will be available in the second quarter of 2008. Like all CGMs you will need a prescription to get hold of one.
A few interesting aspects of the Navigator:
Five-day sensor.
Five direction arrows to indicate rising or falling blood sugar
The receiver has a built-in FreeStyle meter.
Designed to 'accomodate' swimming. Does that mean the receiver is waterproof?
The receiver can be up to 10 feet from the transmitter
You can see a short movie illustrating how the system works. It's available on the Abbott site.
One part of this animation shows the sensor being worn on the back of the arm. That's a very different location that is currently recommended for CGM sensors.
I'll post more news about the FreeStyle Navigator as I learn about it.
Update: My understanding is that the built-in FreeStyle meter is used to calibrate the Navigator. I do not think they support manual input of the values. I'll try to confirm this and update the page when I learn more.
Yesterday Abbott issued a warning for users of Precision Xtra, Optium, and other blood glucose meters. Apparently if the meters are dropped on a hard surface parts of the display may not work properly. They say the lot number or date information may not display correctly.
But I assume this also means that an 8 might display like a 7 or another number. If only some of the segments are wired properly then you could still think it's working when it's actually displaying false values.
So if you drop your meter, use the display check function to ensure the display is fully connected. On the Precision Xtra the display check is done each time you switch on the meter. It should look like the picture on the left.
If you see any part of the display is missing, then my suggestion is to contact Abbott at the number on the back of your meter.
The Diabetes Technology Blog is focused on using technology to live life to the full with diabetes. I review new diabetes technology including: blood glucose monitors; continuous glucose monitors; blood sugar meters; diabetes software and living with diabetes.
About Me
Name: Bernard Farrell
Location: Massachusetts, United States
I was born in Ireland and now live in the US.
I have had Type 1 diabetes for over 36 years. I struggle with my blood sugar, the same as most people with diabetes.
I wear a Cozmo 1800 insulin pump and a Dexcom SEVEN Plus CGM to track my blood glucose levels.
I'm blessed by God, and every day brings the possibility of a cure.