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

Catalog Number	STP-AT-013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994); Foreign Body In Patient (2687)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a broken sensor wire occurred.The sensor was inserted into the arm on (b)(6) 2025.No product or data was provided for evaluation.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).B5: describe event or problem - additional information.D9: device availability - additional information.H2: type of follow up - additional information.H6: adverse event problem - additional information.
Event or Problem Description
It was reported that a broken sensor wire occurred.The sensor was inserted into the arm on (b)(6) 2025.Product has been returned and the investigation is being reviewed.A supplemental report will be submitted after the review is complete.No injury or medical intervention was reported.
Event or Problem Description
After submission of the initial mdr, product was received on 5/16/2025 and it was determined this complaint is not reportable per (b)(4).
Additional Manufacturer Narrative
(b)(4).3004753838-2025-116298 was reported in error.Please disregard initial reporting of this event as this event has now been deemed not reportable.

• 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: 22014831
• Report Number: 3004753838-2025-116298
• Device Sequence Number: 7837266
• Product Code: QBJ
• UDI-Device Identifier: 00386270003621
• UDI-Public: 00386270003621
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: STP-AT-013
• Device Lot Number: 1824315003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 09/29/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 09/29/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: VGO 30 PUMP.
• Patient Age: 80 YR
• Patient Sex: Female