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

Model Number	MT26403-0
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); Hypoglycemic Shock (4575)
Date of Event	05/18/2025
Type of Reportable Event	Death
Event or Problem Description
(b)(6) used the dexcom g7.She used the g7 receiver part number mt26403-0 to monitor and track her glucose levels.On sunday, (b)(6) 2025 we found her unresponsive.She was airlifted to (b)(6) hospital ((b)(6)) in (b)(6).She had suffered seizures which left her in the condition we found her in.She never responded or recovered from the brain damage caused by the seizures and passed away on (b)(6) 2025.The seizures were caused by hypoglycemia.Her glucose was under 40 for over 13 hours once we found her.Her cause of death was metabolic encephalopathy due to hypoglycemia.After she had passed away, a letter from (b)(4) dated (b)(6) 2025, was received stating on (b)(6) 2025 (4 days before (b)(6) hypoglycemic event occurred) dexcom had notified them that certain part numbers of the g7 receivers may experience an issue where the alarm/alert may not provide audio output.Pamela lived alone and depended on her receiver to alert her if her glucose was out of range.There were many tests ran on (b)(6) to determine what had caused her issue.She had her 1st magnetic resonance imaging of the brain showing damage either late (b)(6) 2025, or in the early morning hours of (b)(6) 2025.She was then hooked up to the electroencephalogram to determine if seizures were still occurring.Another mri was completed some days after that still in (b)(6) 2025 still showing the damage.The electroencephalogram picked up more seizures and then the slow brain activity.

• Brand Name: DEXCOM G7 RECEIVER
• Common Device Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM INC.
• MDR Report Key: 22810090
• Report Number: MW5174584
• Device Sequence Number: 4781027
• Product Code: QBJ
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/12/2025

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 Model Number: MT26403-0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White