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

Model Number DEXCOM G6 SENSOR 9500-45

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

Three different dexcom 6 sensors failed to deploy properly within 3 minutes tonight on different areas of my skin, therefore, the sensors did not insert into the skin and were therefore useless.I have successfully deployed and used over 125 of these sensors in the past 4 years.However, this deployment problem was the 4th such problem in the last month.The quality of these recent dexcom 6 sensors is definitely a problem.I have also had 2 sensors that have failed one day prematurely.Additionally, dexcom customer service is very slow in the evening.They say they will call you back within 60 minutes, but it always takes 90+ minutes for a return call.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10378692
• MDR Text Key: 202209633
• Report Number: MW5095934
• Device Sequence Number: 2
• Product Code: MDS
• Combination Product (y/n): N
• 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: 08/04/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DEXCOM G6 SENSOR 9500-45
• Device Catalogue Number: 9500-45
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 107