About a week and a half ago, news came out that there was a recall on Freestyle test strips, one for the strips Omnipod users use and one for users of older Freestyle meters. A lot of patients took to Facebook and Twitter to rant about the various ways Abbott mismanaged the recall announcement.
On Friday, I had the opportunity to speak with Jessica Sachariason, the Public Affairs Manager for Abbott Diabetes Care. I relayed to her the different complaints and concerns that I had heard, and I also asked her a series of questions that I felt Abbott had not yet addressed. However, she had to go back and get the “proper” answers to meet Abbott’s legal department’s requirements, so the answers are somewhat formal and stilted. That being said, I feel a bit better knowing that Abbott has now heard at least some of the complaints and issues that arose from this recall.
What was the issue that caused the erroneous low blood sugars? Was this a technical defect or was it a quality control issue? Why does the Freedom meter work but not the PDM or the older meters?
The root cause has been determined to be a strip manufacturing process error, which only expresses when a strip is used with a non-applied voltage meter (FreeStyle, FreeStyle Flash, and the FreeStyle meter built into the Omnipod system). The manufacturing error causes a decreased response in the system glucose readings. Meters, such as the FreeStyle Freedom, with applied voltage are not impacted and do not express a decreased response in the system glucose readings.
What has been done to resolve this issue?
Abbott has implemented additional quality control processes. At Abbott, the health and safety of patients is our highest priority. The replacement test strips provided to OmniPod users have undergone additional quality testing to ensure they produce accurate results. Going forward, all test strips will receive this testing.
How long had Abbott known about the defect? Does this stem from the November 2013 recall of your test strips?
Following the conclusion of the investigation linked to the November recall, Abbott expanded the recall. Abbott contacted the FDA and promptly initiated a product recall in affected markets and has communicated with all affected parties.
How will customers know they are getting accurate test strips moving forward?
Strip vials with expiration dates of August 2015 or after are strips that are safe for you to use with your OmniPod. Strips with expiration dates before August 2015 should not be used with your OmniPod, but can be used safely with a FreeStyle Freedom meter.
Are you working with pharmacies to prevent old test strips from going to customers who don’t have the Freedom meter? Are pharmacy stocks being replaced with the new test strips? When is it safe to reorder test strips?
Approximately 99 percent of the U.S. customer base who use Abbott’s FreeStyle family of meters are not impacted as they do not use FreeStyle Flash or FreeStyle Blood Glucose Meter systems.
In regards to the question about the replacement strips for OmniPod users, the 400 replacement test strips will be about a 2 – 3 month supply of strips. This amount should cover the customer until the customer’s next visit to the pharmacy to replenish their next test strip supply.
Due to these factors, there is no action required by doctors, pharmacies, and suppliers. If an HCP, pharmacy or supplier has a question, they should contact Abbott’s diabetes care customer service and a representative will provide support.
As mentioned above, strip vials with expiration dates of August 2015 or after are strips that are safe for you to use with your OmniPod. Strips with expiration dates before August 2015 should not be used with your OmniPod, but can be used safely with a FreeStyle Freedom meter.
How are you handling international customers?
Abbott is working with the appropriate Regulatory authorities
Some customers are still complaining about inaccurate readings with the new test strips. Who can customers contact with any concerns they may have?
If a customer is an OmniPod user they should contact Abbott Diabetes Care Customer Service at 1-877-584-5159. If a customer is a user of the FreeStyle Flash or FreeStyle Blood Glucose Meter they should contact Abbott’s Diabetes Care Customer Service at 1-888-345-5364
Why did the letter require a signature? Many users received the letter even later because of this.
The letter required a signature to ensure proof of delivery to the customer affected, and ensure privacy.
Why did so many users find out about the recall via letter four days after the recall was announced on your website? Why did they not come out the same day?
Abbott and Insulet worked to notify OmniPod users as soon possible. We posted the letter to the website as soon as we could and then started the process of sending out the letters to affected customers.
Why have customer service reps been asking for insurance and doctor information? What is the purpose behind that?
Customers are being asked to provide doctor/insurance information in order to determine the most appropriate route for future strip replacements.
It does appear that it will on the onus of the customer to make sure the test strips we receive moving forward are going to be the newest ones, and not older ones that the Freedom meter users can still use. This is disappointing, but I also suppose realistic if Abbott views those test strips as not being completely invalid. Test strips do cost thousands (possibly millions) to manufacture, and if we really are such a small portion of the population, I suppose I can understand. But I wish Abbott put a little more thought into how educating pharmacies about the issue to prevent the older strips from getting into our supplies.
And of course, the logic behind Abbott’s announcement of the recall was severely misguided and mishandled, but that’s hardly something they are going to address. The only thing I can hope is that they think about this a little bit more next time.
That being said: Omnipod is changing meter companies! DiabetesMine shared last week that the new Omnipod PDM will be made with the Lifescan Verio meter, and will hopefully be approved and on the market next year. This is actually not new news… it was first announced that Omnipod and Lifescan were working together in 2012 but that was well before I had any vested interest in the partnerships of Omnipod. So we’ll be stuck with Abbott for a little longer, and while Lifescan is certainly not a perfect company either (their accuracy standards leave something to be desired…) it will hopefully be a better partnership for the companies, and of course, for us!
What do you think of Abbott’s answers?