September 3, 2014

Abbott Receives CE Mark for FreeStyle® Libre, a Revolutionary Glucose Monitoring System for People with Diabetes


Abbott today announced that it has received CE Mark (Conformité Européenne) for its FreeStyle® Libre Flash Glucose Monitoring System, a revolutionary new glucose sensing technology for people with diabetes. The system eliminates the need for routine finger pricks1, reading glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days. In addition, no finger prick calibration is needed—a key differentiator from current continuous glucose monitoring systems. The system will be available in seven countries across Europe in the coming weeks.

 

Abbott's FreeStyle Libre System consists of a small, round sensor—approximately the size of a two Euro coin—worn on the back of the upper arm, which measures glucose every minute in interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin and held in place with a small adhesive pad. A reader is scanned over the sensor to get a glucose result painlessly in less than one second. Scanning can take place while the sensor is under clothing2, making testing more discreet and convenient. Each scan displays a real-time glucose result, a historical trend and the direction the glucose is heading. The reader holds up to 90 days of data, providing a historical snapshot of glucose levels over time. The FreeStyle Libre System software enables the data to be presented in a user-friendly, visual chart for both healthcare professionals and patients, driving a more productive discussion around treatment and any necessary modification.

"The FreeStyle Libre System fulfills a major need for people living with diabetes," said Robert Ford, senior vice president, Diabetes Care, Abbott. "Our customers told us that the pain, inconvenience and indiscretion of finger pricking were the key reasons they weren’t managing their diabetes as well as they should. Addressing these concerns has guided the development of FreeStyle Libre – a transformational product designed to not only remove the pain of finger pricking but also seamlessly integrate into their daily lives."

According to the International Diabetes Federation, there are 382 million people around the globe living with diabetes, more than 56 million of whom live in Europe, and that number is projected to increase by more than 20 percent by the year 20353. FreeStyle Libre System eliminates the challenges of routine glucose monitoring for people with diabetes, enabling them to maintain a better understanding of their glucose levels.

Key features of Abbott's FreeStyle Libre System include:

  • The system requires no finger prick calibration
  • Disposable, water-resistant sensor can be worn on the back of the upper arm for up to 14 days
  • Glucose readings can be taken as many times per day as needed or desired, with a painless one second scan
  • Each scan provides a current glucose reading, 8-hour history and the direction glucose is heading
  • The data generated by the system is designed to provide actionable trends and patterns that may help people determine how to modify food and other behaviors to better manage their diabetes in consultation with their healthcare professionals

"For decades, people with diabetes have had to prick their fingers routinely to check their glucose levels," said Cliff Bailey, professor of Clinical Science and Director of Biomedical Sciences Research at Aston University in Birmingham, England. "The pain and inconvenience of finger pricks has contributed to less frequent testing and suboptimal diabetes management. By eliminating the need for routine finger pricks, the FreeStyle Libre System will significantly advance the field of glucose monitoring. It offers a convenient and painless way to get more frequent glucose readings, which should help to improve diabetes management."

Ambulatory Glucose Profile—Visual Depiction of Glucose Trends

The majority of people with diabetes are not at their target glucose levels4 5 6often because the data generated by their glucose meters don't provide a clear picture of where their glucose has been in the past or how their actions impact their glucose levels. The FreeStyle Libre System provides users and their physicians with the Ambulatory Glucose Profile (AGP), a report providing a visual snapshot of a person′s typical day by utilizing dense glucose data revealing hypoglycemic and hyperglycemic trends to facilitate better patient therapy and education. The data are presented in a single, user-friendly, visual chart providing health care professionals the vantage point to link glucose trends to clinical decision-making, enabling a more productive discussion between health care provider and patient. For more information, go to www.AbbottNextFrontier.com.

A recent study conducted by Abbott7 has shown that the FreeStyle Libre System is clinically proven to be accurate, stable and consistent over 14 days without the need for finger prick calibration. More details on this study will be made available during the Abbott Symposium at the European Association for the Study of Diabetes (EASD) medical conference September 15.

The FreeStyle Libre System will be available in France, Germany, Italy, Netherlands, Spain, Sweden and United Kingdom in the coming weeks and will be available for purchase online through a website in each market.

About Abbott Diabetes Care

Abbott Diabetes Care, based in Alameda, Calif., is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help people better manage their diabetes. Additional information about Abbott Diabetes Care may be found at www.AbbottDiabetesCare.com.

About Abbott

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With an extensive portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott markets its products in more than 150 countries and employs approximately 69,000 people.

Visit Abbott at www.Abbott.com and connect with us on Twitter at @AbbottNews.

March 14, 2014

Abbott Issues Recall of Certain Blood Glucose Monitoring Systems


Abbott is voluntarily conducting a recall for the FreeStyle® Blood Glucose Meter and the FreeStyle Flash® Blood Glucose Meter. These two meters have not been in production since 2010. Other Abbott Diabetes Care meters are not affected by the recall.

 

When used with the Abbott FreeStyle test strips, the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter may produce mistakenly low blood glucose results. Abbott began notifying users on Feb. 19, 2014, immediately after the issue was discovered.

Abbott recommends the following actions for people with meters affected by this recall:

  • Immediately contact Abbott Diabetes Care at 1-888-345-5364 to obtain a replacement meter.
  • If you have access to an alternative glucose meter, immediately discontinue use of the affected meter and take the necessary steps to continue to monitor your blood sugar with the alternative meter.
  • If the only meter available to you is an affected meter, continue to test your blood glucose as recommend by your doctor while you wait for your replacement meter. When using an affected meter, take the following precautions to reduce the chance of a false reading:
    • As stated in the product insert, perform a quality control solution test to confirm that your meter is working correctly. Do not use a test strip vial if control solution results are not within the expected range.
    • Contact your health care provider immediately if your blood glucose result(s) are not consistent with your diabetes history, how you feel, or if you think your results are not accurate (higher or lower than expected). Symptoms of high blood sugar 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.

 

This voluntary recall does not apply to any other Freestyle brand blood glucose monitoring systems – Freestyle Lite®, Freestyle Freedom Lite® or Freestyle InsuLinx® systems can continue to be used with the Freestyle test strips.

For users of the OmniPod® Insulin Management System with the built-in FreeStyle Blood Glucose Meter, please refer to the previously sent letter for Abbott recommended actions or visit https://www.abbottdiabetescare.com/press-room/2014/2014-b.html.

For more information, please visit www.abbottdiabetescare.com/press-room.

About Abbott Diabetes Care
Abbott Diabetes Care, based in Alameda, Calif., is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help people better manage their diabetes. Additional information about Abbott Diabetes Care may be found at www.abbottdiabetescare.com.

About Abbott

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 69,000 people.

Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.

February 19, 2014

IMPORTANT: URGENT PRODUCT RECALL FreeStyle Flash® and FreeStyle® Blood Glucose Monitoring System


Dear Valued Customer,

 

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

No action is required if you do not use the meters pictured below.

  • FreeStyle Flash®
    Blood Glucose Meter
  • FreeStyle®
    Blood Glucose Meter

 

If you are currently using either of the meters pictured above, please take the following steps:

 

  1. Discontinue use of your FreeStyle Flash® or FreeStyle® Blood Glucose Meter and call Abbott Diabetes Care Customer Service at 1-888-345-5364. When you call, Abbott will send you a new FreeStyle® branded meter at no charge.

    If the only meter you have available is a FreeStyle® or FreeStyle Flash® Blood Glucose Meter, 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).

    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.
  2. Upon receiving your new replacement meter, please immediately dispose of your old meter in accordance with your local and state disposal regulations.

There are no other Abbott Diabetes Care products impacted by this issue.

A test strip insert is included with every carton of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips, and provides very important product information. Please read your test strip insert carefully to ensure that you are using the correct test strip type for your Blood Glucose Meter.

We recognize the importance of blood glucose testing and are committed to responding quickly to your needs. We want to assure you that our first priority is you, our customer. We sincerely regret any inconvenience this situation may cause.

We thank you for your continued support of the FreeStyle Blood Glucose Monitoring System and Abbott Diabetes Care. 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

 

February 19, 2014

IMPORTANT: URGENT PRODUCT RECALL FreeStyle® Blood Glucose Monitoring System


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:

  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.

    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.
  3. 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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