Urgent product recall


For those using an Omnipod Insulin Pump system, Abbott has recalled all strips for erroneously reading LOW in the PDM. They are currently replacing only 400 strips at a time. The strips work fine in the Freestyle Freedom and Lite meters, but read much lower in the PDM. This has been an on going problem and Abbott recalled 20 lots of strips this summer, but now has recalled all of them.

Thanks for posting this, Clare. This is the sort of information that needs to be disseminated as widely as possible.

Thanks for posting the warning. Although I just got a 154 reading on the Freestyle Freedom and a 150 on the OmniPod PDM. Still, I'll call them tomorrow and see what they say.

Claire, just curious, where did you get this 'recall' information from? If one calls that 1/800 number, it's very strange, the Abbott Customer Service Rep sounded like she was 12 years old and answered the phone, "hello". Also, they don't even ask to verify information about lot numbers, when you purchased them except at the end of conversation then they want to inquire about info so they can be the ones to ship out and bill your insurance company directly. I called three pharmacies in my area, not one has received any recall information and they would be the first (a pharmacy) to receive recall information and they would have to have LOT numbers to pull products off shelves if this was legit. Has anyone else called?

Hi Sarah, I got the Abbott recall information from a post on the Omnipod Users group on Facebook. When I called the phone number first I had to push 1 to speak English, then I had to push 1 to say I am using the Omnipod PDM as my meter, then someone finally answered with "Thank you for calling the Freestyle recall number" or something like that.
I have so far called the number 3 times. First to get strips, second to get control solution, and finally today to inquire if the strips that I received from Abbott recently were ok to use in my PDM.
They have only once asked me for my doctors, insurance, pharmacy information and when I told her I wasn't giving that out, she just moved on to the next line on her script. I just received an email from Abbott with the FedEx tracking number on my packages.
When I saw the recall notice initially I contacted my Customer Service Advocate at Walgreens mail order service. This is where I get my strips in 90 day increments. I heard back today from her and she said they were unaware of the recall and she would check with the pharmacist to make sure the strips I have are ok to use. I am expecting her to get back to me shortly. My CDE at the Joslin clinic also did not receive a notice of the recall.

because it's a scam, no pharmacy has heard anything about a recall - and there are NO lot numbers associated with this (this felt very strange to me because the customer service rep was so 'odd'). they're trying to get our insurance info so we'll use them as a supplier. if these were truly defected, we'd be getting a notice from Omnipod, they'd be asking for lot numbers, when purchased, etc...and every pharmacy in the country would be pulling them for their shelves and we'd be getting notices from our suppliers, too. Crap...I did give them my info, address, etc...yes, they're sending them out but this is a scam, I believe.

OK so I called the number this morning and went through the whole process. The woman I spoke with said this whole recall process was new and she apologized for being slow. I gave her my insurance info, Doctor info, pharmacy, name, address and phone number. She asked for the lot number of my strips and I gave it to her and she said yes they were being replaced. She told me that they would be shipping me 4, 100 count bottles of test strips, and to discard the ones I have when I get them, not to ship them to them. I got an email today that said they had been shipped. I just called Insulet and asked if the recall was legit and was told yes it is, that the recall had just happened and she thought Abbott would be sending out the recall information to customers, not them. She offered to give me a phone number to call Abbott and I said that wasn't necessary.

Sarah if it's a scam they're going to an awful lot of expense to keep the "ruse" going. They're shipping my strips via Federal Express and not requiring me to return the 1100 strips that I already have. They already had my address because I have contacted them before, they do not have my doctor's name or my insurance information. They recalled 20 lots of these strips for exactly this problem in November.
https://www.abbottdiabetescare.com/press-room/2013/2013-g.html here they gave the lot numbers of the strips that were involved.
Now I believe they have discovered there are far more lots than just the 20 they recalled that have this problem and they are either being forced by the FDA to recall them all or they are doing it of their own accord.
The issue is the Omnipod PDM uses the old technology of the Abbott Freestyle Flash and original Freestyle meter which have not been manufactured since 2010. Not the newer technology of the Freestyle Freedom and Lite meters. The Flash and Freestyle meters were also recalled.

Weird reading this because I just went on omnipod and have had the worst 2 lows almost in my diabetic life but they were legit. My pdm said I was 40 and 36, I felt like I was going out. I just got on the pump 3 day's ago but I just got my strips filled today at the pharmacy. I wonder if I have newer strips because Cvs didn't have them in, they had to order them for me.Interesting

Wow that's scary, it sounds as though your pump settings might be a bit off ? Usually the trainers set the pump up super conservatively at first and you spend the first month higher. I know my blood sugar was much higher to start with. According to Abbott the only strips that you can rely on in the PDM are ones that come directly from them. I have a Dexcom CGM and I also have a Freestyle Freedom, an Insulinx meter and 2 Freestyle Lite meters and the strips I have work fine in all the meters except for the Pod PDM.
Do you have control solution ? If so you might want to do a control solution test on your meter and check that it is accurate.

The strips are working fine and yes you are correct I am setup pretty conservatively,it's the meal time and correction bolus that is not working out i think. I don't think I am counting my carbs correctly. my bg was 100 at dinner and my bolus was 15 units. I was having pizza and some of a sub, enough rabbit food all week. So I thought it was about 90 carbs and they have me on a 1:6 carb ratio. I need to learn this quick because I felt like I was checking out this last low I had. I have been doing mdi forever and have been on the high side for last year,so when I am at 110 I feel a little shaky but funny thing I didn't feel either low coming on today. I only knew when it was almost to late. I wear a dexcom as well and that said I was at 220 when I was at like 55 and tonight it said 108 and I was at 46. I usually test a lot and calibrate often so I think It was just the lag I've noticed with my dexcom. My diabetes educator told me that she hasn't seen somebody drop 300 points in an hour before and I sure as heck haven't ever dropped like that so I think something may have happened with my pod, maybe a bolus went through. I had a communication error earlier. Didn't mean to get sidetracked. Btw I notice that my freestyle strips always test lower than my accucheck but like I said tonight's low's were indeed low, and thank god now I'm back up and they are reading that as well. Interesting though because I had to wait a day from pharmacy to get strips. I got 450 filled, they gave me 50 and ordered 400.

Clare, I'm not sure what 'it is'..it isn't any kind of standard recall as we'd be notified by our suppliers/pharmacies, omnipod, doctors, etc..after all we're using the pod/meter to stay alive. no one asked me for lot numbers, when i purchased them, nothing, just address, phone # and said they'd send 400 and then started to ask and thus trying to collect doctor, insurance info wanting me to order my supplies through them. I'm most certain, as is my pharmacist this isn't the way medical recall information goes out -it's sent via FAX ASAP to every pharmacy/supplier in the country. pharmacies, distributors would be notified first thing, same with any type of food recall and store outlets, etc... they ARE sending them out and it is for abbott but something is very odd about this. Those lot numbers were for 2013 and I NEVER received any type of strip recall notice in 2013 either, did you? Again, CR Abbott Rep never asked me one question about what lot numbers I had, when they were purchased, it was very odd. Why weren't we notified back in november, there are been supposed recalls prior to that and I've never received ANY information. I mean, if this was so important...everyone involved in our care and omnipod use would be notified.

Did you take the bolus for the pizza all at once ? Or did you extend it because you were having pizza which takes a while to digest and is pretty high in fat. I'm sure once you get the timing a bit better you'll be able to avoid the hypos. Glad you're getting back to normal. Communication error just means you don't have the PDM close enough to the pod, they happen fairly routinely if I have the pod on my backside and the PDM in my hand. As soon as I move the PDM closer to the pod it communicates and the error clears.

Here is some more info, (special thanks to MaryMary)


Thanks very much Sue, it's nice to finally hear from Insulet in this mess.

well, they did this too back in November and prior to that and NO ONE was notified, were you? It's just odd, I wasn't asked what model I used for OMNIPOD or anything. We'll see, I guess. Again, usually first notification is to a pharmacy - supplier, if you look at an actual FDA recall it looks very different.

This wasn't an FDA recall it was an Abbott recall. And it is likely that the OP folks have to share their customer information with Abbott but there are probably some HIPA regulations that prevented it. So we will get letters about it either from OP or from Abbott but it will take time.
There's only 2 models of OP and both use the Freestyle strip.

OK, but never got any notice from them back in November 2013 about this either, neither did any of my DTeam, Omnicom, pharmacy, etc...just seems odd if it was so URGENT, ya know. IDK, my OP local rep knows nothing about it either????

November 20, 2013

Important Urgent Product Recall FreeStyle® and FreeStyle Lite® Test Strips
Dear Valued Customer,

Recently, it has come to our attention that certain lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle® Blood Glucose Meters, FreeStyle Flash® Blood Glucose Meters and the FreeStyle® blood glucose meter built into the OmniPod® system. Erroneously low results that are not recognized may pose significant risks to your health.

how do you know the strips are working fine? Abbott isn't saying what lots they're recalling what purchase dates are effected, etc...you mentioned you feel low at 110 due to highs lately. well, if you were at CGM 220 and dropped really fast that would, I imagine, cause that same hypo effect and you said you've never had a low like this and didn't feel it coming on. The messed up thing is, if you changed your PDM code to 19, that POD 46 would probably be very close to your CGM 108. I'm not suggesting changing anything but maybe check on a different meter. This has been a big issue with the POD-Meter. Also, it was recommended to me when first start pump to not eat really high carb meals at first, especially something like pizza which is difficult for most type 1's to eat if pumping or MDI. Maybe stick to smaller, easier carb meals at first. If your basal is set correctly (and this takes time) you're ISF and I:CR should probably not change that much. Again, you're pumping fast acting insulin, it's a whole different ball game. please be careful. What do you set your CGM Alerts at? My CGM is very accurate, I use a dexcom, I tend to go with the numbers on it rather then the pod sometimes but I don't treat with CGM. good luck.

I didn't know I could extend it, I am still learning. I took bolus at once and I knew it seemed to be to much. Especially where I had a bad low at work today. Now I'm very high, roller-coaster since I've been on pump but when I was doing mdi i was just pretty much high so i will get the hang of it, it's progress.