Medical device maker Dexcom says two lots of its Dexcom G7 continuous glucose monitors were stolen during the disposal process and later resold through unauthorized channels in the US.
The company said the sensors had originally been marked as scrap after failing to meet internal quality standards. According to Dexcom, the products were sent to a third-party vendor for destruction and recycling, which is part of the company’s normal quality control process.
But during ongoing quality and accounting reviews, Dexcom discovered that some of the discarded devices had not been destroyed. Instead, the company said, the products were stolen and sold by third parties.
“At this time, Dexcom has identified two lots of Dexcom G7 sensors (1725204004 and 1725069002) that were stolen, sold and used by some customers,” the company said in a statement.
Health risks tied to the affected sensors
Dexcom warned that the stolen sensors may pose safety risks to users depending on the affected lot number.
The company said sensors from lot 1725204004 may not have been properly sterilized, creating “an increased risk of skin infection.” Meanwhile, sensors from lot 1725069002 were found to have “an elevated internal testing failure rate,” which could increase the risk of users receiving no glucose readings at all.
So far, Dexcom says there have been no reports of severe adverse events linked to the stolen devices.
Unauthorized distributor linked to sales
Dexcom traced the sales of the stolen sensors to Pharmsource LLC, a Georgia-based pharmaceutical wholesaler that is not listed as an authorized Dexcom distributor. According to the company, Pharmsource supplies some independent pharmacies and durable medical equipment distributors in the US.
“Nothing matters more to Dexcom than the safety of our users and maintaining the trust of the diabetes community,” said Jake Leach, president and CEO of Dexcom. “We are treating this matter with the utmost seriousness and are working closely with regulators and other authorities to ensure user safety, determine exactly how this product was stolen and hold the perpetrators fully accountable for their crimes.”
Pharmsource has denied involvement in the theft itself. In statements cited by MobiHealthNews, a spokesperson for the company said Pharmsource bought the sensors from licensed distributors and “had no way of knowing the product had been slated for destruction.”
The spokesperson added that the company “immediately conducted a thorough audit” after learning about the issue and is cooperating with investigators.
Customers urged to stop using affected devices
Dexcom says the issue mainly affects users in the US and that it has started notifying customers directly through multiple communication channels.
Users with sensors from the affected lots have been told not to use them and to contact Dexcom for replacements. The company has also launched an online tool that allows customers to check whether their devices are affected.
Dexcom said pharmacies and distributors that purchased sensors from Pharmsource should carefully review their inventory. The company added that products distributed through authorized Dexcom distributors are not affected.
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