Thursday, August 13, 2009

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: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.

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

Wednesday, July 16, 2008

Insulet Omnipod issue

If you're an OmniPod user, you've probably already seen this update. But just in case.

According to the TuDiabetes post
The update states that, if you hear a crackling noise or resistence when depressing the plunger of the fill syringe, you should discard the pod and use a new one - using the defective pod could result in under-delivery of insulin.
You should contact Insulet if you've had any problems.

While at the New England diabetes picnic last weekend I talked with two people who were using OmniPods. They're both very happy with it and in real life the 'pod' doesn't seem to present too many problems.

I'd love to try one out, but I think I'm going to wait until the unit's size (form factor) is smaller. Hopefully Insulet is already working on that.

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posted by Bernard @ 7:26 AM 16 Comments Links to this post  

Wednesday, September 12, 2007

Abbott issues warning about dropped glucose meters

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.

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posted by Bernard @ 9:21 AM 3 Comments Links to this post  

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