PDM Consistently low

All of my strips say they are for the Omnipod. Where do you see it only saying the Freedom Flash?

No, it doesn't say it. This is what Abbott told me on the phone, when I ordered my 400 strips. The current test strips will only work in the separate Freestyle Freedom meter. With the replacement strips, they will work in that meter, the old PDM, the new PDM, and the Flash. (But still not the Lite.)

It is also described in the two recalls notices on the Abbot web page and the Omnipod web page.

http://www.myomnipod.com/newsupdates/
https://www.abbottdiabetescare.com/press-room/2014/2014-b.html

Here are a couple of photos. The first are the new strips lot#1454120 exp 08/15 which came today from Abbott with control solution. They are in a Blue Box but have the same yellow label on the container. The second picture is my own blood glucose test - after washing my hands.


Thanks Clare.

Has anyone said how we will order the correct new strips from our pharmacies in the future ?

The people on the recall line could not answer this.

I am concerned that I will be shipped old strips left on their shelves and be repeatedly calling Abbott.

Isn't the blue box the lite strips? I thought yellow box regular, blue box lite. (Could this be any more confusing?!?) I just got my replacements, and they were all in yellow boxes. Expiration 2/2015.

Strip Recall Update. I spoke with Abbotts Diabetes Contact Person listed on the FDA website.

1. She said this is an extension of the Nov. 2013 recall in their opinion. But the FDA will likely classify this as a new recall.
2. She is going to address the call center information to include the reason why they are asking for insurance, dr, pharmacy. In an unprecedented move they want to appeal to the consumer and make most certain that omnipod users receive the strips intended for the omnipod pdm going forward. She said it was optional, but they were doing it as a courtesy to omnipod users. She said she will handle the call center mixup and make sure reps know the reasons for requesting the information.
3. The replacement strips can be used in the omnipod and other freestyle meters that are not recalled. Use control solution.
4. The old strips can continue to be used in the freedom and other freestyle meters not recalled. Use control solution.
5. They have received too many reports/calls of false low readings in the omnipod and the other recalled meters, so action was taken to remedy this by sending out replacement strips.
6. Her words : Without getting into the "technical" aspect of the replacement strips vs the original strips. Consumers can be certain they have replacement strips for the omnipod if their expiration date is August 2015 and thereafter. This date ensures have the "newest compatible strips with omnipod". These strips meet FDA guidelines for the omnipod.
7. There will be no charges or anything done with personal information that has been provided without your consent. and authorization. Further information will be provided about future "replacement" strips.
8. The replacements are not fully in distribution channel yet, it is recommended once your 400 strips are used, that you contact Abbott again. At that point they will guide you to locations that have the strips in stock or they will replace additional strips at that time.

I am not completely sure about #6 because recently I compained to Abbott Diabetes Care about this problem and was sent 200 replacement strips. They are lot#1371831 with an expiration date of 02/15. I called Abbott to make sure these were ok to use and was told if they came directly from ADC they are fine in the PDM.

You're right, #6 makes no sense. My strips sent today as replacements were Feb 2015, just like you. I called again and have two cases open - one, replacements for all my old strips (not just the 400); and two, how can I tell if strips in the future are the good ones and he said he didn't have that information and would escalate it.

Thank you Clare! If it weren't for you a lot of us, including me, would be just learning of all this today and be at least 4 or 5 days behind the curve. You have my humblest gratitude.
On another note, I just started on the Omnipod in October 2013 and am due to have my first HgA1C since then next week. Typically I'm fairly certain about what my HgA1C is going to generally be, and was looking forward to an even more improved # since starting pumping.
Now I am beginning to prepare myself for feeling cheated.

Likely it WILL still be an improvement, and ANY improvement is always something to be glad about, regardless of how small it may be!

MY A1c fluctuates a bit, but it has almost always been better each time I go. Even though I have been a diabetic for over 30 years, I still have issues, and still run occasional highs etc. Whenever my A1c is below 7.5 I consider it a gain. 99% of the time it is lower than that, with the few times that it was above being typically caused by some other illness along with the diabetes, IE flu, or infection of some sort etc. And, I have to admit, occasionally caused by me eating the wrong things too many times in a row.

Good luck though, and I hope your results turn out better than you expect them to be!

Thanks Clare for the original post; since I swapped over to the PDM meter from my Bayer meter (earlier this month) I have duplicated *every* test I've done; one reading in the PDM, one in the Contour USB, same blood.

For me I've seen high readings and low readings but I'm using three different test strip lots in parallel; I've currently got three open vials because I don't stay in the same place, so I keep a vial everywhere I might go. Those three vials have three different lot numbers, so the statistics I have (when I eventually get all the readings into Excel) may not make much sense.

It will be interesting to see which of my lots, if any, are ok. I've actually got four different lots (in seven boxes - 350 strips) but all lots are 2014/4 or earlier. None of my lots are ones that I've seen identified as OK. Of course Walmart stuck the prescription sticker over both the lot number and the date on the box...

John Bowler

Wow a whole lot has happened since I originally posted this less than a month ago. Yesterday I received 400 strips from Abbott Diabetes Care and 2 letters in a Fed Ex envelope 1 each from Abbott and Omnipod. Today I got home and there were 3 boxes all from Abbott Diabetes Care. In the first box was 400 more strips the next 2 boxes contained control solution in one box was the "normal" and in the other box was the low and high control solution. Talk about shipping costs ? Why didn't they just put it all in 1 box ? I am just so grateful to have a Dexcom because without it I would never have discovered how truly erroneous some of my readings were.

Oh - I mis-read what you wrote. Got it. :)

Clare, those results are absolutely shocking!!

I feel very lucky... The PDM that I just randomly got when I got my starter kit is in line with other meters when I compare. After I read this discussion, I went back and compared my PDM against my Insulinx backup meter, with the same Freestyle strips in both, then freestyle in the PDM and an Insulinx stip in the Insulinx meter. Then compared this to TrueTest strips in my True2Go meter.

Everything came up within +/- 10 mg/dl of each other.

The Gods smiled on me when I joined the Omnipod club :-) Because of everything I've read over the months here about this problem, I am protecting my PDM like it was my child.

Agreed Dave - I would guard that PDM. But the reality is I don't think it is the PDM as much as it is the strips that go in the PDM. The meter in the PDM is old technology. The Freestyle Freedom strips are new technology and they just don't always work correctly.
Abbott decided to recall all the strips used in the Omnipod PDM - even if they're working perfectly well for you, you can still call and get 400 replacement strips free of charge. And you do not have to return the strips you are currently using.
Omnipod customers represent 1% of the entire Abbott blood glucose strip market so it was much more cost effective for them to do a "quiet" recall directly to OP users and not get pharmacies, doctors offices, or the FDA involved.