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

Model Number	9500-155
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Dizziness (2194)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Diabetes mellitus is a known cause of hyperglycemia.
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) 2025.On (b)(6) 2025, the patient was showing symptoms of diabetic ketoacidosis (dka).She felt lightheaded, "smelling of ketones", nausea and vomiting.The cgm was displaying 315 mg/dl while the bg was over 600 mg/dl.The patient was taken to the emergency department and treated with iv fluids.Laboratory tests were also done.Results showed that the patient was not in dka.The patient was discharged the same evening when they stabilized.No data was provided for evaluation.The allegation and the probable cause could not be determined.The reported glucose values fall within the b zone of the parkes error grid.No additional patient or event information is available.

• 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: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 22909680
• Report Number: 3004753838-2025-239007
• Device Sequence Number: 9221442
• Product Code: QBJ
• UDI-Device Identifier: 00386270003386
• UDI-Public: (01)00386270003386(11)230501(17)241031(10)1523140061
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 08/27/2025

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 Expiration Date: 10/31/2024
• Device Model Number: 9500-155
• Device Catalogue Number: STE-AT-030
• Device Lot Number: 1523140061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• 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: INSULIN PUMP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 45 KG