MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6; SENSOR, GLUCOSE, INVASIVE

Catalog Number SIS 0E 003

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)

Event Date 02/01/2021

Event Type  Injury  

Event Description

Rash / inflammation; dexcom g6 sensor adhesive now causing rash, skin discoloration, uncontrollable itching at any application site, including stomach and arms.Interferes with accurate readings of blood sugar and requires daily and multiple calibrations.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11495205
• MDR Text Key: 240403227
• Report Number: MW5100006
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000866
• UDI-Public: 0100386270000866
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: SIS 0E 003
• Device Lot Number: 7283088
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 93