MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

Catalog Number	STK-AT-012
Medical Device Problem Code	Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Codes	Vomiting (2144); Diabetic Ketoacidosis (2364)
Date of Event	06/23/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported via maude (mw5173056) and follow up contact with the patient's parent that the patient passed away.The patient's parent noted that she reported this via maude after receiving the receiver field action letter in the mail and noting that the serial number on the letter matched the patient's receiver.The patient's parent reported that the patient used an insulin pump but did not know which one and believed it to have been in modified closed loop.Use of an insulin pump during the event is not confirmed and no further details were available.The patient had reportedly been sick and vomiting.He was noted to have been alone in his apartment when he was found after being deceased 3 days.The parent reported finding the dexcom receiver next to him, but could not recall any cgm readings, alerts, or alarms from the device at that time.An autopsy noted that he had died from diabetic ketoacidosis (dka).The patient had been evaluated and treated in the emergency department for symptomatic hyperglycemia due to inaccuracies on the cgm approximately 8 months prior to his death.This previous issue coupled with the letter she received made the parent suspicious that the patient's death was the result of a dexcom malfunction, although she could not specify what she believed the problem to be.The patient's parent noted that she had the patient's receiver in her possession and would consider returning it for investigation.Dexcom has sent the patient's mother a return goods authorization to send product in for investigation.If product is returned, a follow up report will be submitted upon investigation completion.No product or data was provided for investigation.Problem could not be confirmed and probable cause cannot be determined.No additional patient or event information is available.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 22680408
• Report Number: 3004753838-2025-205494
• Device Sequence Number: 8431274
• Product Code: QBJ
• UDI-Device Identifier: 00386270002518
• UDI-Public: (01)00386270002518
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K213919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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 Catalogue Number: STK-AT-012
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 22 YR
• Patient Sex: Unknown
• Patient Weight: 64 KG