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

Model Number	MT26403-0
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)
Date of Event	06/23/2024
Type of Reportable Event	Death
Event or Problem Description
My son was alone at his apartment he got very sick and started vomiting he passed away i found his dexcom next to him.I have an autopsy report and police reports verifying the vomit all over the house he was 22 years old he died of diabetic ketoacidosis.Prior to this we were at emergency room when the doctor did lab work and informed us his device was not working at all it said he was fine, but the lab work said differently.

• Brand Name: DEXCOM RECEIVER
• Common Device Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM INC
• MDR Report Key: 22568618
• Report Number: MW5173056
• Device Sequence Number: 13931215
• Product Code: QBJ
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 07/17/2025

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: 12/31/2024
• Device Model Number: MT26403-0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSULIN
• Outcome Attributed to Adverse Event: Death
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White