Dexcom, Inc., a major US maker of continuous glucose monitoring systems (CGMs), is urging users of its G4 Platinum and G5 Mobile CGM systems to test their units and contact the company immediately if alarms for low and high blood sugar levels aren’t functioning. The company announced a voluntary recall of the receivers after consumers complained about the problem.1
The alarms are intended to warn CGM users with type 1 or type 2 diabetes that they may be headed for a dangerous episode of hypoglycemia or hyperglycemia.2,3 This can be life-saving for people who don’t notice early signs of hypoglycemia (low blood glucose) such as feeling shaky, irritable, confused or light-headed. “Although people with diabetes in general have clinical symptoms of hypoglycemia, many of them no longer experience these – a condition called hypoglycemia unawareness. In such settings CGM is the only way to receive external alerts for hypoglycemia, prompting confirmatory finger-stick testing and interventions to correct hypoglycemia,” explains DiabeticLifestyle Editorial Board member Grazia Aleppo, MD, FACE, FACP, Associate Professor in the Division of Endocrinology, Metabolism, and Molecular Medicine at Northwestern University in Chicago.
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 2012.5 “To the best of my knowledge, this is the first time a problem like this has been noted or reported,” she says. “Dexcom has been very proactive in addressing the problem and immediate in its response to patients who reported malfunctioning units. 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.”
According to that letter, the recall 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.6 “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.7 In April, the company released a statement repeating its request that users test the alarms and alerts and contact them by phone or online if there’s a problem. “The immediate health consequences of severe hypoglycemia include loss of consciousness, seizure, and in rare instances death,” that statement says.
In a statement released April 11 about the recall, the U.S. Food and Drug Administration underscored the seriousness of missing an alert by calling it “a Class I recall, the most serious type of recall. Relying on this device may cause serious injuries or death,” in a statement released earlier in April.8
Users should check the audio alert on their CGM system by following these 8 steps, according to Dexcom:
• press the center button on your receiver to access the Main Menu
• scroll down to “Profiles”
• select “Profiles”
• scroll down to “Try It”
• select “Try It”
• scroll down to “55 Fixed Low”
• select “55 Fixed Low”
• verify that you receive vibrations first (vibratory portion of alarm), followed by beeps (audible portion of alarm).
Retest periodically, especially if the receiver has been dropped or gotten wet, the company notes on its website. 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.9 The company notes that it is Dexcom is working an improved speaker for its receivers.10
Dr. Aleppo says CGMs remain an important tool for long-term blood sugar control and for allowing quick action when glucose levels are dropping or rising into unsafe territory. “CGM takes the guessing game out of the day-to-day challenges of diabetes management. People with diabetes who use CGM are able to track their glucose trends in real time as well as over several hours, which is very different from a single time point such is the case with a fingerstick glucose measurement. The rate of change arrows as well as alerts and alarms allow CGM users to determine whether they have impending hyper or most importantly, hypoglycemia,” she says. Research shows that people with diabetes who use CGMs have better A1c levels than non-users, too, she adds.