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The OmniPod Insulin Management System has a built-in FreeStyle Blood Glucose Meter and the FreeStyle® blood glucose test strips may produce erroneously low blood glucose results. This is critical to Diabetics who as a result of inaccurate infor­mation may end up with high blood sugar and poten­tially coma. Symptoms of hyper­glycemia, high blood sugar, may include: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. If you are experi­encing any of these symptoms or are not feeling well, contact your health care profes­sional immedi­ately.

Please take the following steps:

1.  If you are using the FreeStyle® Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM), you must discon­tinue use of any FreeStyle® Blood Glucose Test Strips you may have until you obtain replacement strips from Abbott Diabetes Care. To receive replacement strips at no cost contact Abbott Diabetes Care Customer Service at 1–877-584‑5159.

2.   Continue using your OmniPod Insulin Management System (OmniPod) to deliver your insulin therapy. 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.

3.   If you would like to continue using the OmniPod system to recommend dosing, follow your OmniPod® Insulin Management System instruc­tions for manually entering blood glucose readings.

Refer to the Abbott recom­mended actions and read the FDA press release.