Dexcom, Inc. — Class II: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Ret
Certain lots of Dexcom G7 sensors intended for destruction were stolen and subsequently sold to pharmacies and distributors. These units include lot 1725204004, which was not properly sterilized, and lot 1725069002, which was designated for scrap due to risks of inaccuracy or reading failures.
This affects Dexcom, Inc., distributors, and pharmacies handling the G7 Continuous Glucose Monitoring System, as well as QA and supply chain security professionals responsible for product destruction and diversion prevention.
This incident highlights a significant breakdown in the secure destruction process for non-conforming scrap. Beyond the specific sterility and accuracy failures of the identified lots, the FDA notes that unknown storage and handling conditions during unauthorized distribution introduce additional, unquantified risks to patient safety and device performance.
Verify the integrity of destruction protocols for scrap materials and investigate third-party disposal vendors. Regulatory and supply chain teams should cross-reference inventory against the specific lot numbers (1725204004 and 1725069002) to ensure no unauthorized units are in the clinical or commercial supply.
Class II. Reason: Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.. Product: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System. Firm: Dexcom, Inc. (San Diego CA United States). Status: Ongoing.
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