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

Model Number	MT26423
Medical Device Problem Codes	Unable to Obtain Readings (1516); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2025
Type of Reportable Event	Death
Event or Problem Description
The reporter states her husband passed on (b)(6) 2025.She states her husband had multiple dexcom sensors that would only last one to two days before having connectivity issues.At the time of his passing, the patient was wearing a dexcom sensor that was not showing any readings.No alert went off to notify them.The sensor reading on his phone later said "expired" and noted to replace it.The reporter received a letter from dexcom in july stating that receivers are having issues.Then, they received another letter later stating that her husbands sensor may have been part of a defective batch.

• Brand Name: G7 SENSOR
• Common Device Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 23109095
• Report Number: MW5176276
• Device Sequence Number: 9004544
• Product Code: QBJ
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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
• Device Model Number: MT26423
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 69 YR
• Patient Sex: Male