MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM FOLLOW APP; CONTINUOUS GLUCOSE MONITOR

Catalog Number	SW10497
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an alert/notification settings issue occurred.Data has been received but is pending evaluation.A follow up report will be submitted upon completion.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: DEXCOM FOLLOW APP
• 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: 23357013
• Report Number: 3004753838-2025-297508
• Device Sequence Number: 8899983
• Product Code: QBJ
• UDI-Device Identifier: 00386270001931
• UDI-Public: (01)00386270001931
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: SW10497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: INSULET OMNIPOD5
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 52 KG