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

Model Number M24078

Device Problem Failure to Sense (1559)

Patient Problems Dizziness (2194); Confusion/ Disorientation (2553)

Event Date 02/14/2019

Event Type  Injury  

Event Description

My dexcom g6 sensor repeatedly fails.It is to check my blood sugar.I contacted tech support for a replacement and it seems that only ends up needing to be replaced soon after i place it anyhow.I was hospitalized after my sensor failed.I experienced dizziness and confusion.I contacted technical support and was only asked to reply with the best time to reach me.Also, they provided a website to use which is no longer being supported.Further upsetting is that my sensor today also failed and that¿s my last one.I need them to send a replacement.I also need something other than ¿due to high call volume, your wait may be longer than expected¿ to be the hold music.It is infuriating that it¿s nearly impossible to get through to them.I need them to send a replacement sensor to my home address on file.

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM INC
• MDR Report Key: 8392344
• MDR Text Key: 137984312
• Report Number: MW5084647
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M24078
• 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): Hospitalization
• Patient Age: 43 YR
• Patient Weight: 57