** See our UPDATE Post on this topic, published Feb. 25, 2014 **
Many of you have already heard about the double product recalls issued by Abbott Diabetes Care about 48 hours ago.
This is huge, especially for everyone using the OmniPod system, because the recalled strips are those used in the PDM's built-in FreeStyle meters!
Abbott hasn't yet contacted customers directly, but say they're in the process of sending out letters -- but the D-Community hasn't yet received those and many are confused about what's going on. We've got some pertinent info to share, and will update this post as details come in.
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A news release on the Abbott Diabetes press room page details the issue and has recommendations from Kelly Duffy, VP of Quality Assurance and Compliance:
Recently, it has come to our attention that FreeStyle Blood Glucose Test Strips may produce erroneously low blood glucose results when using the FreeStyle blood glucose meter built into the OmniPod Insulin Management System. Erroneously low blood glucose results that are not recognized may pose significant risks to your health.
In a second related recall, the same is apparently true for the FreeStyle Flash and older FreeStyle blood glucose meters (both of which are no longer made), i.e. they "may produce erroneously low blood glucose results when using FreeStyle Lite and FreeStyle blood glucose test strips."
What should you do if you use any of these? Abbott is recommending that you discontinue use of the effected strips and meters immediately, and call for replacements:
For the OmniPod Personal Diabetes Manager (PDM) - to receive replacement strips at no cost contact Abbott Diabetes Care Customer Service at 1-877-584-5159.
We're being told they'll replace up to 400 strips immediately, and more can be replaced later once they have more supplies stocked up.
When you call, be ready with the following information: test strip info (lot numbers and expiration), the pharmacy you get your test strips from (phone and location), your insurance info, and the phone and address of your doctor.
Authorities tells us that you can and should continue using your OmniPod to deliver insulin, as the system is not compromised in any way.
"While waiting for your replacement strips to arrive, use the FreeStyle Freedom blood glucose meter that you may have previously received with your welcome pack. FreeStyle test strips when used the FreeStyle Freedom blood glucose meter will produce accurate blood glucose results," Abbott states on their website.
For the FreeStyle Flash or FreeStyle meters - call Abbott Diabetes Care Customer Service at 1-888-345-5364 to have Abbott send you a new FreeStyle-branded meter at no charge.
"If the only meter you have available is a FreeStyle or FreeStyle Flash, do not stop testing your blood glucose. Control solution should be used to check the performance of your test strips and meter until you receive your replacement meter. However, if any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia)," Abbott states.
People are also being told to use the alternative FreeStyle Freedom meters, if they have one.
What's the Deal?
We haven't been able to get any substantive response from Abbott Diabetes Care as of mid-afternoon today, but did connect with Insulet's manager of consumer marketing Hjalte Hojsgaard, who says they are working with Abbott to mail out physical letters to all of their customers today (Friday, Feb. 21).
"We would have liked to get the letter out even sooner, and get the word out on our website and social media, but these things sometimes take some time. It really is an issue with the Abbott strips so the ball is mainly in their court... But we're working hard to make sure all of our OmniPod customers get the information they need," Hojsgaard said.
He explained that the issue is strictly with the test strips used in the built-in Abbott glucose meters on both the older-generation blue OmniPod PDM and the newer black model. The glucose meter itself works fine, but an entire run of test strips has been identified to have a defect that can cause false low readings.
Newer models of Abbott glucose meters apparently have the capability to "eliminate the noise" caused by these test strips. But models developed earlier -- including the meter in the OmniPod system and the FreeStyle Flash and older basic FreeStyle meter -- do not. This is why Abbott is issuing two separate recalls; from their side, it's easier to simply upgrade customers to a newer meter model, but since the OmniPod has the meter built-in, the solution there is to replace customers' current stores of test strips.
As noted, this post will be updated as new details come in.