MAUDE Adverse Event Report: DEXCOM, INC. G7 CGM SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Model Number	G7
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Dexcom g7 continuous glucose monitoring sensor failed on insertion.The sensor electrode is clearly visible sticking out of the hole in the sensor body that the introducer passes through, suggesting that the electrode was dragged up and out of the skin by the introducer when the applicator was removed.Sensor application instructions were followed strictly, as they were on (b)(6) 2025 when the same failure mode occurre (b)(4) two sensors out of a shipment of nine have failed so far for a 22% failure rate.This is an unacceptably high number especially compared to the previous g6 sensors, which very rarely failed.Dexcom required us to send the defective sensors back to them when they issued replacements, but i've attached pictures of the two failed sensors that clearly show the electrodes looping up and out of the body of the sensors.Reference report: mw5169645.

• Brand Name: G7 CGM SENSOR
• Common Device Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 21934349
• Report Number: MW5169644
• Device Sequence Number: 8834834
• Product Code: QBJ
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2026
• Device Model Number: G7
• Device Lot Number: 1724316001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSULIN LISPRO ; TANDEM T:SLIM PUMP,
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White