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

Model Number G6

Device Problem Product Quality Problem (1506)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Fluid Discharge (2686)

Event Type  Injury  

Event Description

While wearing my dexcom g6 sensor for the past 9 days, it was often itchy even after using a barrier wipe that dexcom recommended i use.When i took it off last night because it was starting to hurt, i found a rash under the sensor that was oozing fluids and the sensor was stained with reddish blotches.I had similar reactions with the 3 previous sensors, one of which fell off early because of the oozing fluids however the last most recent sensor i used created the worst side effect.I reported the 3 previous reactions to dexcom.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 TRANSMITTER
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10514117
• MDR Text Key: 206523092
• Report Number: MW5096510
• Device Sequence Number: 1
• Product Code: MDS
• 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: 09/07/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2021
• Device Model Number: G6
• Device Lot Number: 7271152
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1