MAUDE Adverse Event Report: Dexcom, Inc. Dexcom G7 15 Day Continuous Glucose Monitoring System

Model Number	9510-007
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Blurred Vision (2137); Dizziness (2194); Diaphoresis (2452)
Date of Event	09/15/2026
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.The wearable was inserted into the arm on (b)(6) 2026.On 09/15/2026, the patient was lying down and browsing on her phone when she suddenly experienced cold sweats, dizziness, and blurred vision.She checked her dexcom cgm, which displayed a glucose reading of 80 mg/dl.Due to her symptoms, she performed a blood glucose meter (bgm) check, which showed a reading of 59 mg/dl.The patient self-treated with apple juice.Approximately 10 to 15 minutes later, she rechecked her glucose levels.Her bgm reading was 62 mg/dl, while her dexcom reading was 84 mg/dl.Despite treatment, she continued to experience cold sweats and dizziness, prompting her to call 911.When paramedics arrived, they performed a glucose check.The bgm reading was 61 mg/dl, while her dexcom displayed 85 mg/dl.Due to her persistent symptoms and low blood glucose levels, paramedics administered a glucose injection (glucagon) and transported her to the hospital for further evaluation.Upon arrival at the hospital, the attending physician checked her blood glucose, which measured 60 mg/dl.Her dexcom sensor was removed to allow for diagnostic imaging (ct scan).The patient was subsequently treated with intravenous (iv) fluids, and her blood glucose levels have been monitored four times daily.The medical team has also been evaluating her pancreas as part of their investigation into the cause of the hypoglycemic event.The patient remained hospitalized at the time of the report and was undergoing continued monitoring and evaluation.At the time of the report the patient was fine.Data was evaluated and the allegation was undetermined.The probable cause could not be determined via data.The reported glucose values fall within the a zone of the parkes error grid at the onset of symptoms.The reported glucose values fall within the b zone of the parkes error grid upon arrival of paramedics.There was not a complete set of reported glucose values available to search within the parkes error grid calculator upon arrival at the hospital.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 hypoglycemia.

• Brand Name: Dexcom G7 15 Day 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.; 232 s dobson rd; mesa AZ 85202
• Manufacturer Contact: jaime chavez ; 6340 sequence dr.; san diego, CA 92121 ; +1(858)200-0200
• MDR Report Key: 50945577
• Report Number: 3004753838-2026-263567
• Device Sequence Number: 18547662
• Product Code: QBJ
• UDI-Device Identifier: 00386270004727
• 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): 09/30/2026

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: 9510-007
• Device Catalogue Number: STE-FT-016
• Device Lot Number: 1726129003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2026
• 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: IV fluids; glucose injection (glucagon)
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 198 LB