DIABETES CARE
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IMPORTANT: URGENT PRODUCT RECALL FreeStyle® Blood Glucose Monitoring System

Published on 2014.02.19

Dear Valued OmniPod® Customer,

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.

Please take the following steps:

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.

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.

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.

As always, control solution should be used to check the performance of your test strips and meter until you receive your replacement test strips. 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 immediately. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia).

Symptoms of 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.

Abbott Diabetes Care will provide further information when you call on the process to obtain your test strips going forward.

FreeStyle® Blood Glucose Test Strips are the only strip type that is approved for use with your OmniPod® Insulin Management System. Please read your product information booklet and test strip insert carefully to ensure that you are using the correct test strip type for your OmniPod® Insulin Management system. OmniPod® Insulin Management System is not labeled for use with FreeStyle Lite® Blood Glucose Test Strips.

We recognize the importance of blood glucose testing and are committed to responding quickly to customers' requests for replacement test strips.

We want to assure you that our first priority is you, our customer. We sincerely regret any inconvenience this situation may cause. If you have any further questions, please call Abbott Diabetes Care Customer Service.

Sincerely,

Kelly E. Duffy
Division Vice President, Quality Assurance and Compliance
Abbott Diabetes Care

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