Meter comparisons

Attended diab. sup. meeting Mon. Speaker
handed out sheet w/ meter comparisons. Is
anyone aware of the fact a couple namebrand
meters don’t meet FDA standards for accuracy?

Wow, that is suprising. Which brands don’t meet the standards?

And they are???

Can you post the sheet you were given? Do you have a scanner where you could make it a PDF and edit this blog to contain it? Or scan it and attach it as a JPG (like a photo)?

And just out of curiosity, was the speaker associated w/ a particular brand of meter?

I found this: http://www.msnbc.msn.com/id/9830521/
but it does not list meters that do not meet standards.

What I saw was FDA looking to change standards

If possible, can you reference how recent the study/report is?

When was that posted? Recently? B/c the date on that from the AP (listed at the top of the article) reads 2005.

And you’re right, the article does not appear to reflect any meter that doesn’t meet FDA standards. It only discusses an issue of the meter possibly switching to foreign units (as compared to American).

To address the issue in the article, I can’t believe that if you test from “feeling high” and receive a number of 5.30 mmol/L, you wouldn’t think that was odd (even if you didn’t notice the mmol/L unit error) and that you’d eat a lot of food or try to administer a large amount of glucose (since most meters in the “mg/dL format” won’t read below about 20 mg/dL, depending on the brand; they will just say LO or something similar). So the real number of reading a 5.3 mmol/L translates into something just over 200 mg/dL, which would make much more sense to go along with any symptoms of an elevated glucose (thirsty, increased urination, etc). Anyway, that’s a tangent in and of itself :slight_smile:

I do know there was a blog post about urging the FDA to tighten the standards of meter accuracy requirements to something more strict than the current +/- 20%. You can read about it here: Tell the FDA +/- 20% Is Not “Good Enough”…Today!

Wasn’t aware…1st time I’ve heard that. What’s the source other then that meeting?

Janny,

I don’t know if the information is similar to what was handed out to you, or something else entirely, but we recently recently a flyer by mail for a new Nova Max Link meter. The flyer mentions "On August 13, 2009 FDA advised healthcare facilities to avoid using glucose test strips with GDH-PQQ enzyme. The FDA advisory notice reported 13 patient deaths caused by maltose interference.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm

The site noted in the flyer above lists a number of meters that use test strips utlizing the GDH-PQQ enzyme.

Cheryl

David’s link meter, Bayer Contour Link is not subject to maltose errors, however, we have had issues with readings that should have reported as “error” that did not and this is something that our endo takes great exception to. David has had “low” readings that he has reacted to, that were not “low” at all and you all know what that means. When I questionned Bayer about our concerns, they told me that sometimes if the blood test is done quickly, maybe he is pressing down into the blood sample with his test strip, too hard, rather than letting it be drawn up into the strip, and that could have been the cause of the two extremely low readings that he had. My endo said that she has always had an issue with that and for a number of years, would not agree to patient use of certain meters, for exactly that reason. If a patient makes an error performing the BG test, she wants the meter to give an error reading and NEVER a false reading. She intended to take note of the incident to take it further with Bayer as Bayer became the only option when test strips to the BD Logic Link meter that medtronic used to supply with their pumps became unavailable where we live, in Canada.

Cheryl