Full Press Release Details
SAN DIEGO--(BUSINESS WIRE)--DexCom, Inc. (Nasdaq: DXCM), the global leader in glucose biosensing, announced today through ongoing quality and accounting reviews it recently identified certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process, then sold by third parties.
Scrapping limited amounts of sensors that do not meet Dexcom standards is a routine part of the company’s quality control process. Sensors identified as scrap are sent to a third-party vendor for destruction and recycling.
At this time, Dexcom has identified two lots of Dexcom G7 sensors (1725204004and1725069002)that were stolen, sold and used by some customers.
“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.”
Dexcom traced sales of this stolen product back to Pharmsource, LLC, who is not an authorized Dexcom distributor but supplies some independent pharmacies and DME distributors in the United States. Pharmacies that purchased product from Pharmsource should take extra care to review their inventory.
Dexcom is notifying customers directly across numerous communication channels. This issue primarily impacts the US, therefore communication to US customers will precede communication to OUS customers.
Users with sensors from affected Dexcom G7 lots (1725204004and1725069002)should not use those sensors and can call Dexcom Customer Support in the US at 1-844-478-1600 to request replacements. More information on how to determine if sensors are from an affected lot and what action to take is available atwww.dexcom.com/theft-check. Dexcom is working to update this website with resources for users outside the US and will notify those users as soon as it is updated.
Dexcom's authorized distributors provide Dexcom G7 sensors to the largest pharmacy retailers and medical distributors in the United States and around the world. Pharmacy retailers and medical distributors who receive Dexcom product from authorized Dexcom distributors are not impacted. Educational samples are also not impacted. The authorized US Dexcom distributor list can be found atwww.dexcom.com/dexcom-suppliers.
Potential harm associated with stolen product
Lot 1725204004:Dexcom G7 sensors that are not properly sterilized have an increased risk of skin infection.
Lot 1725069002:Dexcom G7 sensors from a lot with an elevated internal testing failure rate have an increased risk of having no sensor readings available.
There have been no reported severe adverse events associated with the stolen product.
About DexCom, Inc.
Dexcom empowers people to take control of health through innovative biosensing technology. Founded in 1999, Dexcom has pioneered and set the standard in glucose biosensing for more than 25 years. Its technology has transformed how people manage diabetes and track their glucose, helping them feel more in control and live more confidently.
Dexcom. Discover what you’re made of. For more information, visitwww.dexcom.com