This week, Dexcom issued a notice to their diabetes customers letting them know that the audible alerts on CGM receivers may not always work the way they're supposed to.
The news broke during a Tuesday earnings call with investors, when the California-based company noted that it had a "potential increase in warranty expense" during the final quarter of 2015, relating to an "important customer notification" issued on the speaker component in the hand-held receiver.
The company immediately posted a notification on its website. We heard some rumblings among the patient community that some folks were suspicious of this page, with its simple red lettering, wondering if it might be a case of phishing... but Dexcom verifies the site is on the up and up.
Here is the wording of that consumer alert:
"Dexcom monitors product complaints through our quality program where we have noticed an increase in complaints for audible alarms and alerts associated with Dexcom Receivers (Dexcom G4 PLATINUM, Dexcom G4 PLATINUM Pediatric, Dexcom G4 PLATINUM Professional, Dexcom G4 PLATINUM w/Share, Dexcom G4 PLATINUM with Share Pediatric and Dexcom G5).
As such, we are notifying all Dexcom customers that you may not receive an intended audible alarm or alert if you are relying on hearing the alarm or alert. As a result, you may not detect a severe hypoglycemic (low glucose) or hyperglycemic (high glucose) event.
Dexcom is working on implementation of an improved speaker for our receivers."
The notification page lists 15 different Dexcom receiver part numbers that fall under this alert.
Here is what they recommend customers do:
- Test the alerts to make sure they work properly, especially if the receiver's been dropped or gotten wet. You can go into the "Profiles" section in the receiver menu and scroll down to the "Try It" menu, which allows you to hear the different vibrating and audible alarms.
- If you find that your alarms and alerts are not working, or you have any other questions about this issue, you can call Dexcom's dedicated toll-free hotline at (844) 607-8398 or their direct line in San Diego at (858) 291-1700.
Note that this did not start out as a product recall, but a customer notification that Dexcom says the FDA is also aware of.
We are told Dexcom is replacing receivers that have these speaker issues.
Dexcom also says every customer using these receivers, going back to the initial G4 receiver, will be receiving a certified letter of notification.
Checking the list of receiver numbers, sure enough I saw my own receiver listed. The notification site took me through a few questions and asked me to try out my alerts. Thankfully, they all worked on my G4 with Share receiver, so I guess I'm fortunate.
But as a customer, I really appreciate how Dexcom handled this -- using the investor call, social media channels, proactive outreach to the DOC, a special site online, and its own call center and certified mailing to tackle this potential problem head-on. Way to use all of your tools, Dexcom!
UPDATE: On April 11, the FDA issued a Class 1 recall relating to this Dexcom receiver alarm issue. The recall impacts 263,520 receivers shipped out between October 2012 and March 2016.
Dexcom Business Updates
This led the headlines, but was not the only news on Tuesday to come out of Dexcom's Q4/Full Year 2015 earnings call in which they offered business updates for investors. We tune into those calls, as they're often full of rich detail on where product launches stand and what we can expect down the road.
Here's what we learned:
Receiver: Dexcom remains confident that it will have a newly-designed receiver by the end of the year. We've reported that before, most recently in our D-Tech 'Spectations 2016 news coverage. Dexcom's new receiver will sport a touchscreen and possibly an added feature with the G5 Mobile app that will display Insulin On Board (IOB) info fed from partner pumps like Animas Vibe, Tandem t:slim, and Insulet OmniPod. Very cool!
Inserter: The company is also excited about its new insertion system that will launch toward the end of the year, that will allow us CGM'ers to use a handheld applicator that you just stick on the skin, and push a button to insert (no more plunger!). Dexcom CEO Kevin Sayer says this will be the first new inserter the company has had since launching the CGM 11 years ago, and will be the biggest operational and manufacturing change the company has endured to date.
G6: Plans also remain for Dexcom to file its next-generation G6 model later this year, with that hopefully gaining FDA approval and coming to market by the end of 2016 or early 2017. That next-gen sensor will offer improved accuracy with a different algorithm, likely only one calibration needed daily, and probably a 10-day wear (instead of the current FDA-approved 7 days).
Despite the receiver notification just issued, there are a lot of exciting updates happening with Dexcom. We hope quality control remains a priority, as it has throughout the company's history in bringing us new CGM tech -- and we have no reason to doubt that's the case.