September 17, 2013

Abbott Receives CE Mark for FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System™


Abbott announced today it has received CE Marking (Conformité Européenne) in Europe for the FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System™. The new icon-driven system provides sleek design, visual glucose trend indicators and insulin logging – all delivered in a single device to support daily diabetes management.

 

According to the World Health Organization, the prevalence of diabetes is increasing in the European region. Approximately 10 percent of women and men aged 25 years and older in Europe are living with diabetes1, which makes diabetes one of the most prevalent chronic conditions.

Features of Abbott's FreeStyle Optium Neo System include:

  • A high contrast, icon-driven display designed for ease-of-use
  • Small, sleek meter design
  • Blood glucose trend indicators, which visually notify patients when they are experiencing hypo- or hyperglycemic trends (low or high blood glucose levels)
  • An insulin dose feature, which allows healthcare professionals to program a patient's insulin plan into the meter. Beginning from the physician's recommendation in the dose guide, the meter is designed to allow patients to log actual insulin doses by tapping the arrows up or down. This feature is designed to enable patients and their healthcare professionals to review logged insulin doses along with glucose results.

"The FreeStyle Optium Neo System is our latest advance based on the innovative technology that is at the heart of both our Precision and Optium products. It combines powerful features, ease-of-use and the ability to analyze important glucose trends in a single device," said Heather Mason, senior vice president, Diabetes Care, Abbott. "The device's advanced design and technology enables the ability to track glucose trends and log insulin, which may help improve the patient's daily diabetes management. This system is one more example of how Abbott is focused on meeting the needs of patients."

The system is designed to be used with FreeStyle Optium blood glucose and ketone test strips, which are currently available in Europe. Abbott recently marked the 25th anniversary of its invention of commercial biosensor technology for diabetes patients, the forerunner of today's FreeStyle Precision and FreeStyle Optium strips.

Abbott's FreeStyle Optium Neo System will be available throughout Europe in the coming weeks. Individuals with diabetes who are interested in the FreeStyle Optium Neo System should consult with their healthcare professional.

About Abbott Diabetes Care

Abbott Diabetes Care, based in Alameda, California, 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 (NYSE: ABT) 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 70,000 people.

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

July 25, 2013

Abbott Receives FDA Clearance for FreeStyle Precision Pro Blood Glucose and β–Ketone Monitoring System™


Abbott today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System™, an advanced blood glucose monitoring system designed to address the key needs of hospital customers: high accuracy, efficient operation, dual-band wireless access to immediate test results, and helps in the reduction of the risk of test strip cross-contamination.

 

 

"The FreeStyle Precision Pro system represents a significant step forward as we work to provide tools to improve the way hospitals manage patients' glucose levels," said Heather L. Mason, senior vice president, Diabetes Care, Abbott. "It makes the data available in real time, thanks to the meter's new wireless capabilities. With its individually foil-wrapped test strips, the system is also designed to help reduce test strip cross-contamination in hospital environments."

Key features of Abbott's FreeStyle Precision Pro system include:

Addresses Hospital Needs for Cross-Contamination Control

  • Abbott's FreeStyle Precision Pro system is the only inpatient blood glucose monitoring system among leading hospital brands to use individually foil-wrapped test strips,1 helping reduce the risk of test strip cross-contamination of blood and bacteria.2This Abbott exclusive advantage helps hospitals comply with the Centers for Disease Control and Prevention regarding protection of unused supplies.3
  • The device conforms to FDA requirements for cleaning and disinfection, which require devices to be disinfected after each use. The FreeStyle Precision Pro Meter also offers a replaceable strip port that can be removed for replacement on-site.

Dual-Band Wireless Connectivity Enables Real-Time Access to Test Results and Improves Staff Workflow

  • Abbott's FreeStyle Precision Pro system allows for real-time, dual-band wireless communication between the handheld meter at the patient bedside and the hospital information system, giving clinical staff immediate access to patient test results throughout their facility. The dual-band wireless technology enables the flexibility of wireless access within a hospital's Wi-Fi-enabled network when properly configured. The system is designed so that clinical operators need not interrupt their busy workflow to conduct routine docking or attach a data cable to download patient results, saving time while also providing access to real-time data. This helps ensure immediate access to test results through the hospital's electronic medical record system, and to facilitate clinical decision whenever it is needed.

Designed with Higher Performance Characteristics

  • The FreeStyle Precision Pro system features a new algorithm to correct for hematocrit interference. The test process occurs in five seconds for prompt and accurate delivery of test results.

2D Barcode Technology for Patient Identification

  • The new system adds technology to read newer 2D barcodes, which are becoming more prevalent in healthcare identification systems. This technology enhances the accuracy of patient identification with TrueID™ technology.

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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 (NYSE: ABT) 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 70,000 people.

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

April 15, 2013

IMPORTANT: URGENT PRODUCT RECALL FreeStyle InsuLinx Blood Glucose Meter


Dear Valued Customer,

If you use, recommend, or sell the FreeStyle InsuLinx Blood Glucose Meter, we want to make you aware that Abbott Diabetes Care is recalling FreeStyle InsuLinx Blood Glucose Meters. Our records indicate that you may have received a FreeStyle InsuLinx meter. Please read the following information carefully.

Incorrect Test Results At Extremely High Blood Glucose Levels

We have determined that at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result.

Example: For a blood glucose value of 1066 mg/dL, the meter will display and store a value of 42 mg/dL (1066 mg/dL – 1024 mg/dL = 42 mg/dL).

The likelihood of experiencing extremely high blood glucose levels 1024 mg/dL and above is rare. However, when they occur, they are a serious health risk and require immediate medical attention. If the FreeStyle InsuLinx meter displays an inaccurate low result, there may be a delay in identification and treatment of severe hyperglycemia (high blood glucose levels). This could lead to serious injury or death.

If you are using the FreeStyle InsuLinx Meter, you should immediately take one of the following actions to address this issue with the meter:

  • You can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. The software update will allow you to maintain settings and historical data on your meter.
  • You can contact Abbott Diabetes Care Customer Service at 1-800-222-3100 to expedite return and replacement of your FreeStyle InsuLinx meter at no charge. Replacements are available, and Abbott will send a meter to you immediately upon request.

 

Until you are able to update the meter software or until your requested replacement meter arrives, the current FreeStyle InsuLinx meter may be used; however, if you experience symptoms that are not consistent with your readings, you should contact your healthcare professional and follow his or her treatment advice.

Extremely high blood glucose levels require immediate medical attention. If you experience symptoms, which are not consistent with your readings you should contact your healthcare professional and follow his or her treatment advice.

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

Healthcare Professionals: If you have FreeStyle InsuLinx Blood Glucose Monitoring Kits, you are advised to immediately discontinue dispensing them to your patients. To arrange for product return and replacement, please call Abbott Diabetes Care customer service at 1-800-222-3100. While we are notifying patients directly, we also request your assistance in sharing this information with your patients who use the FreeStyle InsuLinx Meters.

Retailers/Distributors: If you have FreeStyle InsuLinx Blood Glucose Monitoring Kits in your current stock, you are advised to immediately discontinue distributing this product. Abbott Diabetes Care will be replacing your FreeStyle InsuLinx Blood Glucose Monitoring Kits with product that does not have this issue. To arrange for product return and replacement, please call Abbott Diabetes Care customer service at 1-800-222-3100. While we are notifying our patients directly, we also request your assistance in sharing this information with your customers who use the FreeStyle InsuLinx products.

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 InsuLinx Blood Glucose Monitoring System and Abbott Diabetes Care. If you have any further questions, please call Abbott Diabetes Care Customer Service at 1-800-222-3100.

Additional information about this recall can be found at www.abbottdiabetescare.com.

 

Abbott Diabetes Care

 

March 18, 2013

IMPORTANT: MEDICAL DEVICE CORRECTION Precision XceedPro Blood Glucose and β-Ketone Monitoring System


Dear Valued Customer,

This letter contains important information for users of the Precision XceedPro Blood Glucose and β-Ketone Monitoring System. Please review the information carefully.

Abbott Diabetes Care (ADC) has become aware of the following issues:

  1. A small number of Precision XceedPro Blood Glucose Test Strips lots produce control solution results out of range and higher than expected percentage Coefficient of Variation and Standard Deviation with controls. This issue does not affect patient blood glucose or β-ketone results, as confirmed through our internal testing of retained strips and performance monitoring program.
  2. Precision XceedPro Monitors with serial numbers beginning with “KC” do not fully support a subset of the following barcode types: Interleaved 2 of 5 (I 2 of 5), Code 128 and Code 39. As stated in label copy, if you cannot scan a barcode using the barcode scanner, the data entry keypad on your Precision XceedPro Monitor allows you to manually enter identification numbers and letters.

 

ADC has a firmware update to the Precision XceedPro Monitor to address these issues. If you have seen these problems and would like to schedule the update, please contact us at ADCTechnicalSupport@abbott.com or call 1-877-529-7185, and press the pound (#) key to connect with an Abbott Diabetes Care Representative.

You may continue to use the Precision XceedPro Blood Glucose and β-Ketone Monitoring System to test patients and test with controls. It is important to compare control solution results to the ranges stated on the test strip insert included with each lot.

We want to assure you that our first priority is you, our customer. We sincerely apologize for any inconvenience this may cause. We appreciate that you have chosen Abbott Diabetes Care as your partner for hospital blood glucose management.

Should you have any questions, please contact Technical Support at 1-877-529-7185, and press the pound (#) key or your Abbott Diabetes Care Representative.

Sincerely,

Quality Assurance and Compliance

Abbott Diabetes Care

March 4, 2013

IMPORTANT: MEDICAL DEVICE CORRECTION Precision XceedPro Blood Glucose and β-Ketone Monitoring System


Dear Valued Customer,

Abbott Diabetes Care has confirmed issues regarding Precision XceedPro Monitors with serial numbers beginning with “KC” in which the monitor fails to establish communication when docked with docking stations distributed prior to December 2007. Docking stations distributed prior to this date contain two (2) data ports at the back of the docking station.

Precision XceedPro Monitors with serial numbers beginning with “KC” will work with docking stations that contain a single data port at the back of the docking station. Precision XceedPro Monitors beginning with serial number “XP” will work with all docking stations.

Our shipping records indicate that you received one or more affected docking stations prior to December 2007 and have also received Precision XceedPro Monitors with serial number beginning with “KC”. If you have affected docking stations, Abbott Diabetes Care will replace them free of charge to resolve the communication issues.

Please discard any docking stations with two (2) data ports that you have at your facility to ensure that they will not be used with Precision XceedPro Monitors beginning with serial number “KC”. These 2-port docking stations will no longer be supported by Abbott Diabetes Care.

The customer reply form should be completed and returned by 01 May 2013 via e-mail to ADCTechnicalSupport@abbott.com. Please complete this form to indicate how many affected docking stations you have at your facility, even if that number is zero.

Should you have any questions, please contact Technical Support at 1-877-529-7185, and press the pound (#) key to connect with an Abbott Diabetes Care Representative.

We want to assure you that our first priority is you, our customer. We sincerely apologize for any inconvenience this may cause. We appreciate that you have chosen Abbott Diabetes Care as your partner for hospital blood glucose management.

Sincerely,

Quality Assurance and Compliance

Abbott Diabetes Care



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