The company identified the lots — stolen during the destruction process — through ongoing quality and accounting reviews. At this moment, the company reports two G7 lots (1725204004 and 1725069002) as 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 says scrapping limited amounts of sensors that fail to meet its standards comes as a routine part of its quality control process. It sends sensors identified as scrap to a third-party vendor for destruction and recycling.
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The San Diego-based company traced sales of the stolen product back to Pharmsource, LLC, which is not an authorized Dexcom distributor but supplies some independent pharmacies and durable medical equipment (DME) distributors in the U.S., according to a news release. Dexcom says pharmacies that purchased product from Pharmsource should take extra care to review their inventory.
According to the company, the issue primarily impacts U.S. customers. Users with sensors from the two affected lots should not use those sensors.
The affected lots each received a scrap designation due to potential harm associated with their use. Sensors in Lot 1725204004 do not have proper sterilization and have an increased risk of skin infection. Those from Lot 1725069002 have an elevated internal testing failure rate, meaning an increased risk of no available sensor readings.
Dexcom reports no serious adverse events associated with the stolen product.
Pharmsource issues statement
A spokesperson shared the following statement on behalf of Pharmsource:
“Pharmsource purchased the Dexcom G7 sensors in question from licensed distributors and had no way of knowing the product had been slated for destruction. When we learned of this issue, we immediately conducted a thorough audit of our inventory and took appropriate remedial measures. To be clear, Pharmsource had zero involvement in Dexcom’s destruction process, which is where Dexcom reports the theft occurred. Any insinuation to the contrary is patently false. We will continue to assist authorities in their investigation to determine how Dexcom’s destruction protocols resulted in stolen product entering the commercial market.”
