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

Model Number	9500-161
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Urinary Frequency / Polyuria (2275); Elevated ketones/Diabetic Ketoacidosis (2364); Lethargy (2560)
Date of Event	08/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred.On 08/09/2026, the patient experienced lethargy and increased urination.The patient was brought to the hospital and when a fingerstick was taken the cgm reading was low, and the blood glucose reading was 500 mg/dl.Ketones were high, but no specific value was reported.The patient experienced diabetic ketoacidosis and was treated with intravenous insulin and fluids.No further medication was reported and the patient was discharged after spending less than 24 hours at the hospital.There was no documentation of further medical evaluation or intervention.At the time of the report the patient was stable.Data was evaluated and the allegation was undetermined.The probable cause could not be determined via data.The reported glucose values fall within the d zone of the parkes error grid.The data investigation did not find blood glucose calibration values to compare to cgm values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications.No additional patient or event information is available.
Additional Manufacturer Narrative
(b)(4).Diabetes mellitus is a known cause of hyperglycemia and/or 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 Contact: jaime chavez ; 6340 sequence dr.; san diego, CA 92121 ; +1(858)200-0200
• MDR Report Key: 50696291
• Report Number: 3004753838-2026-246643
• Device Sequence Number: 9685181
• Product Code: QBJ
• UDI-Device Identifier: 00386270004116
• UDI-Public: (01)00386270004116(11)250901(17)270228(10)1825275004
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 9500-161
• Device Catalogue Number: STP-AT-013
• Device Lot Number: 1825275004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/16/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Omnipod 5; intravenous fluids; intravenous insulin
• Outcome Attributed to Adverse Event: Other
• Patient Age: 5 YR
• Patient Sex: Female