FDA recalls real-time glucose monitors after 56 injuries
The U.S. Food and Drug Administration announced a recall of multiple active glucose monitoring units manufactured by Dexcom due to a malfunction in the receivers. The speakers on these devices may fail to alert wearers when blood sugar levels become dangerously high or low. Typically, the monitors emit an alert sound; however, in Dexcom G6, G7, ONE and ONE+ products, reports indicate that the alarms do not always function properly.
There have been at least 56 injuries associated with the error, the FDA said. However, no deaths have been reported.
Dexcom devices are part of continuous glucose monitoring systems that track the blood sugar levels of people with diabetes in real-time. While they are found in healthcare facilities, they are often used at home under the supervision of a healthcare provider.
Because of the high risk of death associated with dangerously low or high blood glucose levels, the FDA has given this recall a Class I designation—the most serious type.
What is being recalled?
The Dexcom products included in this recall are the G6, G7, ONE and ONE+ receivers. The table below provides model and serial number details that can be used to identify defective devices.
Next steps
Only the receivers on the affected systems are being recalled. All users should check their inventory to see if they have a device with a defective receiver. If so, contact Dexcom for a replacement at 1-844-478-1600.
The company notified all known customers about the issue in a letter sent on June 9. The notice advises anyone in possession of any glucose monitor—even those not included in this recall—to test the speakers regularly to ensure they are functioning properly.
The FDA and Dexcom are asking that the recall notice be shared. It can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.