MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 PROFESSIONAL SYSTEM; CONTINUOUS GLUCOSE MONITOR

Catalog Number STP-PR-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2023

Event Type  Injury  

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).H6 codes: health effect - clinical code - appropriate term / code not available fda code: 4581 will be replaced with code e2014 for tissue breakdown.

Event Description

Dexcom was made aware on (b)(6) 2023, that on (b)(6) 2023 , the patient experienced a skin reaction.It was reported that the physician that the unknown patient experienced a skin issue with lipoatrophy from wearing the g6 sensor.The event occurred an unspecified number of days after the sensor had been inserted.The physician declined to provide additional information.No additional event or patient information is available.

• Brand Name: DEXCOM G6 PROFESSIONAL SYSTEM
• Type of Device: 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: 17647758
• MDR Text Key: 322241037
• Report Number: 3004753838-2023-173613
• Device Sequence Number: 1
• Product Code: QII
• UDI-Device Identifier: 00386270001092
• UDI-Public: 00386270001092
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: STP-PR-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other
• Patient Sex: Prefer Not To Disclose