Dexcom Recalls More than 2 Million CGM Receivers for Lack of Audible Alarm

Dexcom recalls more than 2 million CGM receivers for lack of audible alarm

Severe adverse events, including seizure and loss of consciousness, were potentially linked to the issue, based on 56 reports Dexcom received.

FDA Issues Emergency Recall of 2 Million Dexcom Devices Over Life-Threatening Fault

The US Food and Drug Administration (FDA) has issued its highest-level recall on more than two million Dexcom Continuous Glucose Monitoring (CGM) devices, warning diabetic patients and healthcare providers of a critical safety fault that could pose life-threatening risks. Dexcom, a leading manufacturer of CGM devices widely used by people with diabetes to monitor blood sugar levels in real-time, has been forced to recall specific models of its G…

Time in range is ‘directly related’ to wound healing in diabetic foot ulcer, study finds – EDFN

New research has identified that glycaemic control is directly related to ulcer wound healing in non-complicated diabetic foot ulcer (DFU). With DFU a significant risk factor for limb amputation, the Spanish study set out to evaluate the relationship between the parameters provided by Continuous Glucose Monitoring and the healing time of DFUs in the real world. The study included people with type 2 diabetes with DFUs grade I–II (stage A–C) of th…

Dexcom has a Class I CGM receiver recall

The One+ offering with the sensor, app and receiver. [Image courtesy of Dexcom]The FDA’s recall database today posted notices related to a Class I recall for continuous glucose monitor (CGM) components made by Dexcom (Nasdaq:DXCM). Dexcom’s recalls relate to its Dexcom One and One+ offerings and the G6 and G7 CGMs. The One and One+ systems, which are mainly the company’s commercial CGM offering outside the U.S., feature the established G6 and G7…