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 Problems Erythema (1840); Pain (1994); Fluid Discharge (2686); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 03/29/2023

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).

Event Description

It was reported that a skin reaction occurred.On (b)(6) 2023, the patient experienced a skin reaction at the needle puncture site.The patient developed redness, inflammation, swelling, drainage, infection, and pain.The patient was evaluated by a healthcare provider (hcp) who diagnosed the patient with an infection at the needle puncture site, prescribed an unspecified oral antibiotic and performed an incision and drainage procedure.The patient¿s symptoms and infection improved post-treatment.No product was provided for evaluation.The allegation and a probable cause could not be determined.No additional patient or event 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: 16839947
• MDR Text Key: 314259773
• Report Number: 3004753838-2023-086783
• Device Sequence Number: 1
• Product Code: QII
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• 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
• Device Lot Number: 5316322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2023
• 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): Other
• Patient Sex: Male