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

Model Number	9501-161
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Skin Infection (4544)
Date of Event	02/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Labeling indicates: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e.G.Redness, swelling, bruising, itching, scarring or skin discoloration).
Event or Problem Description
It was reported that a skin reaction occurred.The sensor was inserted into the arm on (b)(6) 2026.Prior to sensor insertion the area was prepped with alcohol.According to the reporter, on (b)(6) 2026, the pediatric patient experienced a skin reaction with pustules and an infection at the needle puncture site.Photos of the reported skin reaction in the complaint record were reviewed.The reaction was confirmed and is consistent with similar local skin responses previously observed and assessed in association with the device use.The findings are within the expected range of reactions known to occur at or around the device application area.There is no documentation of scarring, or systemic involvement.The image shows a localized circular area of erythema at a prior sensor insertion site with a small lesion.The surrounding skin appears intact with mild redness and faint residual markings consistent with prior adhesive use.No open wound, drainage, blistering, or ulceration is visible.The patient visited an healthcare provider and was prescribed an oral antibiotic flucloxacillin (250mg/5ml 4x a day).There was no documentation of further medical intervention.At the time of the report, the patient¿s condition is fine.No data or product was provided for investigation; however, a photograph was provided.The allegation was confirmed via photographic inspection.The probable cause could not be determined.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 (Section G): DEXCOM, INC.; pmt 818; persiaran cassia selatan 3; bandar cassia 14110 ; MY 14110
• Manufacturer Contact: jaime chavez ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 24738025
• Report Number: 3004753838-2026-122712
• Device Sequence Number: 9840320
• Product Code: QBJ
• UDI-Device Identifier: 00386270004048
• UDI-Public: (01)00386270004048(11)251101(17)270430(10)1825336014
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 9501-161
• Device Catalogue Number: STP-GT-001
• Device Lot Number: 1825336014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2025
• 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: INSULET OMNIPOD5.; ORAL ANTIBIOTIC.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 10 YR
• Patient Sex: Male