So far, there have been 13 complaints recorded … 510(K)s with Product Code = QBJ and Original Applicant = Dexcom, Inc. Dexcom Inc quote is equal to 356.900 USD at 2020-12-30. Third Quarter 2020 Financial Highlights: Revenue grew 26% versus the same quarter of the prior year to $500.9 million U.S. Designed to help diabetes patients keep track of their blood glucose levels with ease. Any correspondence with the company is responded to with a boilerplate response. The Recalling Firm is currently updating their product labelling as following: We launched our latest generation system, the DexCom G6 ® integrated Continuous Glucose Monitoring System, or G6, in 2018. Unless the context requires otherwise, the terms “we,” “us,” “our,” the “company,” or “DexCom” refer to DexCom, Inc. and its subsidiaries. This may result in failure to treat hypoglycemia from missed low sensor glucose values and alerts or by causing other errors in diabetes management decisions. February 13, 2020 / 9:01 AM / MoneyWatch Medtronic is recalling more than 322,000 of its insulin pumps because of a missing or broken component that can lead to over- … The recall affects 10 models in the U.S., only three of which are currently being sold, ... Like most companies in 2020, Dexcom (NSDQ:DXCM) faced a … I have had a Medtronic pump for 25 years, but have been counting down the days until my 670G went out of warranty to I could switch to the T-slim/Tandem with Dexcom. Dexcom Inc. is recalling it’s G4 Platinum and G5 Mobile continuous glucose monitoring system receivers due to an alarm failure. If you are taking hydroxyurea, your sensor glucose readings will be higher than your actual glucose, which could result in missed hypoglycemia alerts, or errors in diabetes management, such as giving yourself a higher dose of insulin due to falsely high sensor glucose values. Recalls Alaris™ System Pump Module … "Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia; it is known to interfere with readings from your sensor. The company has undertaken the recall because of reports that the G4 and G5 audible alarm systems are not sounding. The majority of commercial insurance plans have written positive coverage decisions for both personal and professional use of CGM. National payers such as Cigna, Humana, Aetna, United Healthcare and Anthem WellPoint are currently covering these CPT codes, although the coverage criteria may differ between personal and professional use of CGM. Dexcom released an update for the app which corrected the problem for those impacted and prevented the problem from occurring for users not affected. -Sickle cell disease I called Dexcom the first time after switching out my sensor, and had them send a replacement. .Should you have any questions regarding hydroxyurea or alternative glucose monitoring approaches, please contact your healthcare. * Dexcom has not tested these approaches, nor do we endorse these specific approaches. Dive Brief: Dexcom's beat-and-raise third-quarter results appeared not good enough for investors Tuesday, who sent shares down 9% following a revenue pre-announcement and news of a C-suite retirement.Dexcom's 26% rise in revenue compared to chief competitor Abbott's roughly 36% organic growth in FreeStyle Libre glucose monitor revenues announced last week. Insulet is planning to launch the OmniPod Horizon system later in [Image courtesy of DEXCOM] The level of inaccuracy depends on the amount of hydroxyurea in your body. A year later it starts again with getting the reauthorization. On the positive side, a verdict from a special FDA panel means Dexcom may soon be able to change its CGM’s intended use to replace fingerstick glucometers. Device ... CME America Updates Recall of BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion: 08/05/20: Verathon, Inc. HOWEVER, dealing with customer service and actually receiving the required sensors, on time, is a nightmare. SAN DIEGO --(BUSINESS WIRE)--Oct. 27, 2020-- DexCom, Inc. (Nasdaq: DXCM) today reported its financial results as of and for the quarter ended September 30, 2020 . A German government agency released a recall notification in February. Third Quarter 2020 Financial Highlights: Revenue grew 26% versus the same quarter of the prior year to $500.9 million. The company has undertaken the recall because of reports that the G4 and G5 audible alarm systems are not sounding. 2020 Medical Device Recalls. Based on our forecasts, a long-term increase is expected, the "DXCM" stock price prognosis for 2025-12-23 is 960.598 USD. Dexcom is targeting a late 2020 initial launch of its next-gen G7 model, which has been in the works for several years as a collaboration with Verily (formerly Google Life Sciences). U.S. revenue growth of 29% and international revenue growth of 17% Recalls and safety alerts mobile application. Been on Dexcom for almost 3 years without issue. The G7, apparently, will not immediately make the G6 system obsolete; Sayer coyly alluded to rechanneling the G6 “into other areas.” I can't recall the name though. Dexcom announced today that due to the public health crisis of COVID-19 and the need to preserve personal protective equipment and reduce the frequency of hospital staff exposure to the coronavirus, the company is making its Dexcom G6 CGM System temporarily available for remote patient monitoring in the hospital setting. Dexcom chairman, president & CEO Kevin Sayer had to… The company identified potential interference from hydroxyurea. Defective Medical Device, Product Liability, Product Recall Attorney A Massive Recall Issued By FDA Over A Defective Medical Device Safety: Dexcom Diabetes Monitoring System Despite the advances in the field of modern medicine, certain healthcare problems continue to represent major medical concerns for millions of patients everywhere. Dr. Aleppo says Dexcom has been proactive in notifying users of the 263,520 Dexcom affected CGM units sold in the U.S. since October of 2012. All Dexcom Devices Last Updated: September 10, 2020 This is a summary of a clinical article published by clinicians independent from Dexcom, based on their knowledge and experience. The recall covers 263,520 CGMs in the U.S., and a total of 270,111 worldwide, according to FDA. -Chronic Myelogenous Leukemia (CML) -Head and neck malignancies, and Industry News & Recalls June 17, 2020 Tandem Diabetes Care Announces Expanded Pediatric Indication of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology June 13, 2020 Medtronic Shares Study Results on First of Its Kind Extended Wear Infusion Set from American Diabetes Association Conference This may result in failure to treat hypoglycemia from missed low sensor glucose values and alerts or by causing other errors in diabetes management decisions (for example, hypoglycemia resulting from an insulin dose based on a falsely elevated sensor glucose reading). Customers are instructed to talk to their physician about alternative glucose monitoring approaches, and if they are unsure if they have been prescribed hydroxyurea. The audio alert on some of the receivers may not warn patients of hypoglycemia and hyperglycemic events, when their blood glucose levels are too low or high. In a recent interview with MedTechDrive, Sayer said that Dexcom is targeting a late 2020 debut for the new G7 system. ... Like most companies in 2020, Dexcom (NSDQ:DXCM) faced a … That recall affects 263,520 Dexcom CGM units sold in the US since October, 2012. Ultimately, the company posted a net loss of $20 million, despite a 47 percent year-over-year increase in revenue, from $93.2 million in Q2 2015 to $137.3 million this past quarter. Dexcom G4 Continuous Glucose Monitoring System - Sensor, Dexcom G5 Mobile / G4 Platinum Sensor Kit. Medtronic received FDA clearance on Aug. 31, 2020 for its 770G, which is the BLE-enabled component of its future 770G device. Specialist advice should be sought about your specific circumstances. Dexcom’s biggest triumph and its biggest let down this quarter both involved the FDA. “Dexcom has been very proactive in addressing the problem and immediate in its response to patients who reported malfunctioning units. Instructions for Downloading Viewers and Players. Angela Bruno, a product safety and consumer law solicitor said: Like most companies in 2020, Dexcom (NSDQ:DXCM) faced a number of challenges brought on by COVID-19, public unrest and more. Dexcom and Verily are launching the G7, a much thinner, less expensive, fully disposable continuous glucose monitor , in the US in about two years – late 2020 is the current estimate for the launch, followed by broader availability in 2021. Qbj and Original Applicant = Dexcom, Inc later it starts again with getting the.... Months to get set up with Dexcom due to the subject matter government agency a! 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