FDA Warning for Abbott

[morrisma]

I love my Freestyle Lite meter but the FDA just smacked Abbott for some problems with strips and with their Navigator product.

Read here

Sounds like you need to check the strips and wash the draw site well and maybe know when you are ingesting maltose of other fake sugar stuff.
Mike

[dbaratta]

I love my Freestyle Lite meter but the FDA just smacked Abbott for some problems with strips and with their Navigator product.

Read here

Sounds like you need to check the strips and wash the draw site well and maybe know when you are ingesting maltose of other fake sugar stuff.
Mike

I still have my meter, I only use it in conjunction with my bayer, that meter for me has good readings when the number is close to normal, but when it is higher it can be higher than the bayer by 40 or more, it was very scary for me to see that!!!

[morrisma]

I 'calibrate' my meter to lab results taking a reading on the freestyle right before I get vampired. I am usually withing 10-20 points which makes me quite confident in my meter but...
Mike

[Mound31]

I love my Freestyle Lite meter but the FDA just smacked Abbott for some problems with strips and with their Navigator product.

Read here

Sounds like you need to check the strips and wash the draw site well and maybe know when you are ingesting maltose of other fake sugar stuff.
Mike

Clicking "Read here" brings me to a medscape website that needs a password--not good for me since I don't have one.

I have a Freestyle Lite and it gave me 3 consecutive reading from the same stick of 81, 159 139. I called the company and the tech said that was within specs but did send me a new meter. I would hate to be basing my insulin on that.

[HeartMan]

I have spent quite a bit of time on the phone with Abbott regarding their products. I'll share my thoughts and experiences:
1) There are three issues addressed in the FDA letter:
a) The manufacturing plant is understaffed and in the FDA's judgment too low to ensure accuracy of Abbott's product. The FDA cited scratches on the test strips as evidence that the understaffing is a problem.
b) Continuing problems with the Navigator Continuous Blood Glucose Monitoring System, which Abbott claims is based upon not being able to meet demand.
c) The current test strips use a technology that could produce false highs if the patient is receiving certain medications, usually given in a hospital setting. Abbott's response is that it has received approval for strips that use a different technology and those strips will be available later this year.
2) For years I used Abbott's (Therasense) FreeStyle products. Those strips had to be coded to the meter, but accuracy was phenomenal. Most of the time the reading from my meter taken at the same time as a blood test at the lab matched the lab's reading, when it was off, it was no more than 2 or 3 points. Then along came no-code technology, and accuracy went out the window.
3) I began taking my meters (both a FreeStyle Lite and a FreeStyle Freedom Lite) to the hospital lab. The numbers the meter gave me were 19% and 25% too high. When I called Abbott's Diabetes Care Support, their rep said they were fine. I asked how she was calculating that, and she said they take the two readings, average them, and see if they are within 20% of the average. I insisted that the base to be used was the lab results from the hospital where they calibrate their machines every week. Ultimately she said that customer satisfaction is a priority and sent me out replacement meters. The new FreeStyle Lite tested within 3%, and I'm using that one exclusively now.
4) As to getting different numbers: one factor that comes into play is whether the blood sample flows freely from the stick, or if we have to milk our fingers to get enough blood. Something happens to the blood that raises the number if we squeeze our fingers to get enough of a sample, so that could explain the higher numbers if they came from the same stick. I would encourage anyone questioning the accuracy of their FreeStyle product to compare their readings take at the same time as your labs are done. If you take insulin and are not satisfied with the numbers, get back on the phone with Abbott and tell them what's going on and request a newer meter. (Hopefully all this will be resolved when the new technology strips replace the current ones.)

[poodlebone]

I've tried two different Freestyle meters - the original one and the Freestyle Lite. Both of these meters read higher, often much higher, than any other meter brand I've tried. I'm Type 1 and am hypo unaware so the higher readings could cause major problems for me. If I correct for what the Freestyle meter says is 225, but every other meter says 145, that would lead to a bad low.

Everyone likes to compare meters and all of the meter companies tell us not to do that. It can drive you crazy. The same meter can give different results in multiple tests. I think it's mostly a matter of choosing one meter and sticking with it. You'll eventually learn how it works (reads a little lower or higher than Meter X or your lab results, for example). As long as you know how the meter reads you'll probably be fine. I'm sure if I was forced to use a Freestyle meter I'd eventually adapt to the higher numbers, but I honestly believe they are wrong. Accu-Chek Aviva also read higher for me but not as high as Freestyle. I use Lifescan One Touch Ultra meters (several models) and sometimes Bayer Contour USB. The Bayer & One Touch are generally close to each other.

[valerief]

Clicking "Read here" brings me to a medscape website that needs a password--not good for me since I don't have one. .

You can read the article here

The FDA warning letter

and

Abbott customer disruption notice

I wrote about this on our blog today:
FDA Warning Letter for Glucose Testing Kits


hope that helps

[morrisma]

Sorry the link did not work for everyone. I had no problems but thanks to valerie for reposting the stuff and HeartMan for the detailed post. I use a FreeStyle Lite and have not run into the high readings others have reported. I will watch it closely and I may bring in my 2 spare FreeStyles for tests at the next lab blood draw.
Mike

[Lupin]

Medscape is directed primarily at physicians and other health care providers, but I signed up for it long ago when researching osteosarcoma and the drugs used to treat it (our first Lab died from it). It's a free sign-up; a friend of mine to whom I recommended the site said he signed up as Albert Schweitzer and said he had the patent on Schweitzer cheese (knowing him, I believe that's how he signed in!). Although their sign-up policy may not be too strict, their information seems good, and often very technical. It's at a much, much higher level then their companion site for the common folk, WebMD.