MAUDE Adverse Event Report: Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring System

Catalog Number	SW11677
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Malaise (2359)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an alert/notification settings issue occurred.The sensor was inserted into the skin.On (b)(6) 2026, it was reported that the patient reported having unspecified high cgm values.She reported she received no alerts from her dexcom mobile app notifying her of her hyperglycemic state but only found out her cgm value was elevated by manually checking her device.The patient was also wearing a tandem insulin pump.The patient began to feel nauseous, unwell, and had ketones.Emergency medical services (ems) was called and the patient was taken to the emergency room (er).At the er, the patient was treated with insulin, an anti-nausea medication, and iv saline.The patient was discharged after approximately nine hours.The patient was ¿fine¿ at the time of report.Data has been received but is pending evaluation.A follow up report will be submitted upon completion.No additional patient or event 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.Diabetes mellitus is a known cause of hyperglycemia.

• Brand Name: Dexcom G6 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 ; +1(858)200-0200
• MDR Report Key: 50736715
• Report Number: 3004753838-2026-249248
• Device Sequence Number: 10633700
• Product Code: QBJ
• UDI-Device Identifier: 00386270000804
• UDI-Public: (01)00386270000804
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: DEN170088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: SW11677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/11/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Anti-nausea medication.; IV Fluids / Saline.; Insulin.; Tandem Tslim pump.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female