Dexcom reported that two Dexcom G7 continuous glucose monitor sensor lots were stolen during disposal and later resold through unauthorized channels in the US. The sensors had been marked as scrap after failing to meet internal quality standards and were sent to a third-party vendor for destruction and recycling as part of normal quality control. During quality and accounting reviews, Dexcom found that some discarded devices were not destroyed and were instead stolen and sold by third parties. Dexcom identified lots 1725204004 and 1725069002 as stolen, sold, and used by some customers. Lot 1725204004 may not have been properly sterilized, increasing skin infection risk. Lot 1725069002 showed an elevated internal testing failure rate, increasing the risk of no glucose readings. Dexcom reported no severe adverse event reports so far and traced sales to Pharmsource LLC, a wholesaler not listed as an authorized distributor.
"At this time, Dexcom has identified two lots of Dexcom G7 sensors (1725204004 and 1725069002) that were stolen, sold and used by some customers."
"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."
"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."
"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."
#medical-devices #continuous-glucose-monitoring #device-safety #supply-chain-diversion #sterilization-and-infection-risk
Read at TechRepublic
Unable to calculate read time
Collection
[
|
...
]