Dexcom Recall of Continuous Glucose Monitor Receivers

Written by Sari Harrar
Reviewed by Grazia Aleppo MD, FACE, FACP

Company urges consumers to test alarms and alerts, which may not sound when a user’s blood sugar is dropping or rising beyond a healthy range.

Dexcom, Inc., one of the largest makers of continuous glucose monitoring systems (CGMs) in the U.S.1 is recalling receivers for its G4 Platinum and G5 Mobile CGM systems because of consumer complaints that alarms for low and high blood sugar levels may not sound. The alarms are intended to notify users with type 1 and type 2 diabetes before they experience dangerous episodes of hypoglycemia or hyperglycemia.2,3

The voluntary recall applies only to receivers that are not working properly, according to Dexcom. The company first alerted users to the potential alarm failures via certified letters in February and recommended that all users test their units. (For testing directions, see below.) “If you rely on hearing the alarm or alert, you may not detect a severe hypoglycemic (low glucose) or hyperglycemic (high glucose) event,” the letter stated. 4 In an April 11, 2016 press release, the U.S. Food and Drug Administration called the recall a Class I recall, the most serious type of recall. Relying on this device may cause serious injuries or death.” 5

The recall affects 263,520 Dexcom CGM units sold in the U.S. since October of 2012. It applies to the Dexcom G4 PLATINUM Receiver, Dexcom G4 PLATINUM (Pediatric) Receiver, Dexcom G4 PLATINUM (Professional) Receiver, Dexcom G4 PLATINUM Receiver with Share, Dexcom G4 PLATINUM (Pediatric) Receiver with Share and the Dexcom G5 Mobile Receiver, according to the company.7

“Dexcom has been very proactive in addressing the problem and immediate in its response to patients who reported malfunctioning units,” says EndocrineWeb Editorial Board member Grazia Aleppo, MD, FACE, FACP, Associate Professor in the Division of Endocrinology, Metabolism, and Molecular Medicine at Northwestern University in Chicago. “Dexcom has shipped by Fed-Ex replacement units to any patient that has reported problems with the 55 Fixed Low alarm feature. In addition, they have sent to all users a certified letter alerting them of this potential issue.”   

CGMs for Catching Hypoglycemia Early

CGMs can help people with diabetes track sensor glucose trends throughout the day and over time, leading to better A1C levels, Dr. Aleppo notes. They are used along with finger-stick blood glucose checks with a glucometer to confirm levels. CGMs are especially useful for people with diabetes who no longer notice early warning signs of hypoglycemia such as feeling shaky, irritable, confused or light-headed. A special danger: People with hypoglycemia unawareness may not be awakened by low blood sugar symptoms at night. 8 Untreated, hypoglycemia can lead to a seizure or unconsciousness according to the American Diabetes Association. 9

 “In such settings CGM is the only way to receive external alerts for hypoglycemia, prompting confirmatory testing and intervention to correct hypoglycemia,” Dr. Aleppo says. Noticing the signs of falling blood sugar, or hearing an alarm on a CGM, gives a person with diabetes time to check their blood sugar and ingest glucose or simple carbohydrates to raise it.

Testing Dexcom Alarms and Alerts

Users should check the audio alert on their CGM system by following these 8 steps, according to Dexcom:

If the alert isn’t working property, contact Dexcom at their free hotline number: (844) 607-8398 or online at www.dexcom.com/notification right away.10 The company notes that it is Dexcom is working an improved speaker for its receivers. 11

 

Sources

1. Future Market Insights: Sales of Continuous Glucose Monitoring Systems to Reach US$ 445.8 Million by 2015 End http://www.futuremarketinsights.com/press-release/CGM-market. Published September 23, 2015. Accessed April 18,2016

2. Dexcom certified letter “Urgent Field Safety Notice” February 2016.

3. Dexcom statement April 11, 2016: Dexcom, Inc. Issues Press Release To Supplement Previous Customer Notification.  http://www.fda.gov/Safety/Recalls/ucm495481.htm

4. Dexcom certified letter “Urgent Field Safety Notice” February 2016,

5. US Food and Drug Administration website: Dexcom Inc. Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers Due to Audible Alarm Failure. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm495448.htm. Updated April 11, 2016. Accessed April 18, 2016.

6. Dexcom certified letter “Urgent Field Safety Notice” February 2016.

7. Dexcom certified letter “Urgent Field Safety Notice” February 2016.

8. American Diabetes Association: Hypoglycemia (Low Blood Glucose)

Accessed April 18,2016.

9. American Diabetes Association: Hypoglycemia (Low Blood Glucose)

Accessed April 18,2016.

10. Dexcom certified letter “Urgent Field Safety Notice” February 2016.

11. Dexcom certified letter “Urgent Field Safety Notice” February 2016.

 

Continue Reading

Google + Dexcom = High-Tech, Low-Cost Diabetes Devices