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Archive - 03 - 2013

Statement by the American Diabetes Association on the Passing of Richard R. Rubin, PhD, CDE Richard Rubin obit

Posted by dlife on Wed, Mar 27, 13, 12:03 PM 0 Comment

ALEXANDRIA, VA--(Marketwire - Mar 26, 2013) - The American Diabetes Association mourns the loss of Richard R. Rubin, PhD, CDE from Monkton,  Maryland. Dr. Rubin served as an Association volunteer for more than 30 years, having been President, Health Care and Education in 2006-2007, chair of the Association's Committee on Professional Councils, and chair of the Council on Behavioral Medicine and Psychology. He was a member of the Association's Program Publications Editorial Board, Scientific and Medical Programs Oversight Committee, Health Care Finance Administration Advisory Group, and Health Care and Education Advisory Board, Pinnacle Society and he chaired the Task Force on the Delivery of Diabetes Education and Medical Nutrition Therapy. He has received multiple awards from the Association over the years, including the Outstanding Educator in Diabetes Award in 1997, Levine Medal for Service in 2007 and the Addison B. Scoville Award for Outstanding Volunteer Service in 2010.

"Dr. Rubin made remarkable contributions as an Association volunteer and diabetes educator throughout his career," commented Larry Hausner, Chief Executive Officer, American Diabetes Association. "His commitment in the fight to stop diabetes was truly inspirational. He will be greatly missed by the many lives he has touched and we send our condolences to his family."

Dr. Rubin was also a professor of medicine and pediatrics at the Johns Hopkins University School of Medicine. He had been involved as a principal or co-investigator in several long-term studies in the management of diabetes, including the Diabetes Prevention Program and Look AHEAD trials. Additionally he was an investigator in the POWER trial of weight loss in primary care settings.

LifeScan Announces Voluntary Recall of All OneTouch VerioIQ Blood Glucose Meters

Posted by dlife on Mon, Mar 25, 13, 03:24 PM 0 Comment

March 25, 2013 (Johnson & Johnson) — At extremely high blood glucose levels (1024 mg/dL and above), the OneTouch VerioIQ Meter will not provide a warning and will shut off Milpitas, CA – March 25, 2013 – LifeScan, Inc. is initiating a voluntary recall and replacement for all of its OneTouch VerioIQ blood glucose meters in the United States, effective immediately. LifeScan is recalling and replacing all OneTouch VerioIQ Meters because at extremely high blood glucose levels of 1024 mg/dL and above, the meter will not provide a warning that the blood glucose is extremely high and will shut off, thereby potentially leading to incorrect treatment and delaying proper treatment. The likelihood of experiencing an extremely high blood glucose level of 1024 mg/dL or higher is remote; however, when such a blood glucose level occurs, it is a serious health risk requiring immediate medical attention. Because these products do not provide an appropriate warning at glucose levels of 1024 mg/dL or higher, diagnosis and treatment of extreme hyperglycemia may be delayed or incorrect treatment may be given resulting in potentially serious health risk or fatality. Patients who are using the OneTouch VerioIQ Meter should:
— Contact LifeScan Customer Service at (800) 717-0276 to make arrangements to receive a replacement meter at no charge and to speak with a LifeScan representative. Representatives are available 8 a.m. to 10 p.m. EDT Monday through Sunday (LifeScan U.S. Customer Service). — Seek additional information about this recall on www.onetouch.com. Please note that patients may continue to test with their OneTouch VerioIQ Meters while they wait for their replacement meter to arrive as long as they are aware of this issue. However, LifeScan advises that if the meter unexpectedly turns itself off during testing, this could be a sign of extreme hyperglycemia requiring immediate medical attention and the patient should call a healthcare professional. "Our patients' safety is our number one priority," said Dr. Michael Pfeifer, LifeScan's Chief Medical Officer. "When we learn that a product does not fully meet our expected standards, we will voluntarily notify our customers and patients and take corrective action. We regret the inconvenience these actions may cause. However, we will always err on the side of caution and make a decision that is in the best interest of our patients." Notifications are being sent to all registered users, healthcare professionals, pharmacies and distributors wherever these products are sold. LifeScan estimates that there are approximately 90,000 active OneTouch VerioIQ Meter users in the U.S. The company is in the process of implementing an update to the meter to address the issue, however, the timing to resume shipments of OneTouch VerioIQ Meters has not yet been determined. In the U.S., this recall affects the VerioIQ blood glucose meter from OneTouch. To date, no adverse events or patient injuries related to this specific issue have been reported for the OneTouch VerioIQ Meter. All other OneTouch blood glucose brands sold in the U.S., including OneTouch Ultra Meters, OneTouch Select Meters and OneTouch Verio Test Strips, are not affected and can continue to be used with confidence. Outside the U.S., this recall affects three Verio blood glucose meters from OneTouch. Three OneTouch Verio Brand Meters are being recalled outside the U.S. because of incorrect glucose value display or record storage at extremely high glucose levels. These meters include the OneTouch VerioIQ, OneTouch VerioPro and OneTouch VerioPro+ Brands. To date, no adverse events or patient injuries related to this issue have been reported globally for the OneTouch VerioIQ and OneTouch VerioPro+ Meters. For the OneTouch VerioPro Meter, LifeScan has received one report of a serious adverse event, which occurred outside the United States. The company has not determined whether the OneTouch VerioPro Meter was a causal factor. LifeScan has notified the U.S. Food and Drug Administration (FDA) and healthcare authorities around the world of this voluntary action. LifeScan is working with the individual regulatory agencies around the world where the affected products have been sold.

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