MAUDE Adverse Event Report: Dexcom, Inc. Dexcom G7 Continuous Glucose Monitoring System

Model Number	9500-161
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a wearable failure occurred.The wearable was inserted into the arm on (b)(6) 2026.The date of the event is an approximation.On 03/24/2026, the patient reported experiencing a dexcom g7 sensor failure that displayed a "replace sensor" message, resulting in the loss of sensor functionality.The patient did not have a replacement sensor available at that time.The exact time of the sensor failure was unknown.No symptoms or treatment were reported immediately following the malfunction, and it was unknown whether the patient performed fingerstick blood glucose (bg) measurements after the sensor failed.On (b)(6) 2026, at an unknown time, the patient reported developing diabetic ketoacidosis (dka) and was subsequently hospitalized.The patient stated that her blood glucose level was greater than 400 mg/dl prior to hospitalization and approximately 756 mg/dl upon arrival at the hospital.The patient reported remaining hospitalized for approximately five days, including treatment in the intensive care unit (icu).The patient further reported that the event caused a prior bypass to fail and that she now uses a wheelchair; however, no additional information was available regarding these reported outcomes.The patient was unable to recall further details related to the event, hospitalization, or treatments received.No additional documentation regarding medical evaluation or intervention was available.At the time of reporting, the patient was reported to be stable.Data was provided for investigation.The allegation was confirmed via data.The probable cause was determined to be missing sample failure via data.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 and diabetic ketoacidosis.

• 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 (Section G): Dexcom, Inc.; pmt 818; persiaran cassia selatan 3; bandar cassia 14110 ; MY 14110
• Manufacturer Contact: jaime chavez ; 6340 sequence dr.; san diego, CA 92121 ; +1(858)200-0200
• MDR Report Key: 50694521
• Report Number: 3004753838-2026-246482
• Device Sequence Number: 21231410
• Product Code: QBJ
• UDI-Device Identifier: 00386270004116
• UDI-Public: (01)00386270004116(11)250901(17)270228(10)1825270009
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Model Number: 9500-161
• Device Catalogue Number: STP-AT-013
• Device Lot Number: 1825270009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/28/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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
• Outcome Attributed to Adverse Event: Disability; Other; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 150 LB