- Drug Coverage
- Hypertrophic Cardiomyopathy (HCM)
- Vaccines: 2023 Year in Review
- Eyecare
- Urothelial Carcinoma
- Women's Health
- Hemophilia
- Heart Failure
- Vaccines
- Neonatal Care
- NSCLC
- Type II Inflammation
- Substance Use Disorder
- Gene Therapy
- Lung Cancer
- Spinal Muscular Atrophy
- HIV
- Post-Acute Care
- Liver Disease
- Pulmonary Arterial Hypertension
- Safety & Recalls
- Biologics
- Asthma
- Atrial Fibrillation
- Type I Diabetes
- RSV
- COVID-19
- Cardiovascular Diseases
- Breast Cancer
- Prescription Digital Therapeutics
- Reproductive Health
- The Improving Patient Access Podcast
- Blood Cancer
- Ulcerative Colitis
- Respiratory Conditions
- Multiple Sclerosis
- Digital Health
- Population Health
- Sleep Disorders
- Biosimilars
- Plaque Psoriasis
- Leukemia and Lymphoma
- Oncology
- Pediatrics
- Urology
- Obstetrics-Gynecology & Women's Health
- Opioids
- Solid Tumors
- Autoimmune Diseases
- Dermatology
- Diabetes
- Mental Health
Accu-Chek infusion set recalled
Roche recently recalled its Accu-Chek FlexLink Plus infusion sets globally because they may under-deliver insulin to patients.
Roche recently recalled its Accu-Chek FlexLink Plus infusion sets globally because they may under-deliver insulin to patients.
Some customers reported a kinked or bent tube when inserting the infusion set. “If this remains unnoticed it can result in under-delivery, leading to elevation of blood glucose levels,” said Todd Siesky, spokesman for Roche Diabetes Care. Fourteen adverse events related to the bent tube had been reported to FDA at the time of recall, according to Siesky.
More than 140,000 ACCU-CHEK FlexLink Plus infusion sets have been recalled in the United States. Siesky did not know how many sets have been recalled globally. ACCU-CHEK FlexLink Plus was launched in November 2010, and is sold directly to patients via distributors.
Other Accu-Chek infusion sets and insulin pumps are not affected by the recall and can continue to be used by patients.
Patients should return the Accu-Chek FlexLink Plus sets to their healthcare providers or caregivers. Adverse events should be reported to FDA’s MedWatch Safety Information and Adverse Reporting program at www.fda.gov/MedWatch, or call (800) 332-1088.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
Diabetes Management & Telehealth with Leslie Kolb
June 11th 2020Association of Diabetes Care and Education Specialists, chief science and practice officer, Leslie Kolb chats with MHE Associate Editor Briana Contreras in MHE's newest podcast Tuning into the C-Suite about diabetes management and how it's affected by the use of telehealth, especially during the current and trying times of the COVID-19 pandemic.
Listen
