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

Catalog Number	UNKNOWN
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fatigue (1849); Blurred Vision (2137); Dizziness (2194); Coma (2417); Diaphoresis (2452); Confusion/ Disorientation (2553)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an adverse event occurred.The wearable was inserted into the skin.On (b)(6) 2026, it was reported that at around 12:00 pm, the patient was at home when she received an urgent low alert.The patient could no longer recall the specific reading at this time.She didn´t had a fingerstick to use for comparison.She said that she was feeling dizzy, disoriented, having a blurred vision then she passed out.At an unspecified time, her mother found her unconscious and immediately called an ambulance.The entire day, the patient kept vomiting with dizziness, sweating, confusion, disoriented, loss of consciousness, and blurry vision.Her mother called an ambulance for a rescue since the patient was still unconscious.The patient couldn¿t provide the bg nor cgm readings, nor if there was any medication provided while in the ambulance.When she arrived at the hospital, she was admitted to the icu and she was in a coma for 2 days.The patient regained consciousness on (b)(6) 2026.She didn´t knew the medication they gave her during the time she was in a coma and even after she regained her consciousness.She was discharged on (b)(6) 2026 at 2:00 pm with a bg reading of 110 mg/dl and stable reading on the dexcom device.At the time of the report the patient was tired but feeling better.No other details were documented.No product or data was provided for investigation.The allegation and the probable cause cannot be determined.No additional event or patient information is available.
Additional Manufacturer Narrative
(b)(4).H6 medical device problem code - 3191 - patient was unable to identify device issue therefore a more specific code could not be selected.

• 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: jaime chavez ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 24743144
• Report Number: 3004753838-2026-123120
• Device Sequence Number: 8731087
• Product Code: QBJ
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BETA BIONIC ILET PANCREAS SYSTEM
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 82 KG