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

Model Number DEXCOM G6 SENSOR

Device Problems Mechanical Jam (2983); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 09/26/2020

Event Type  Injury  

Event Description

Wife is using dexcom g6 cgm.When using the applicator to install the sensor it failed, did not fully install the sensor with the installer needle getting jammed and stuck approximately 1/2 inch in her abdomen.This was a very painful almost 45 min long experience to remove a needle stuck in with adhesive.The worst part is she went to install the next one and the very same thing happened only on the third one did it work.And come to find out dexcom knows about this problem already and has for some time and seems to have done relatively little to fix it.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM,INC.
• MDR Report Key: 10606089
• MDR Text Key: 209456081
• Report Number: MW5096965
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 09/28/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2021
• Device Model Number: DEXCOM G6 SENSOR
• Device Lot Number: 5278436
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 57