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

Lot Number 7273649

Device Problems Retraction Problem (1536); Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Pain (1994); Tissue Damage (2104)

Event Date 11/06/2020

Event Type  Injury  

Event Description

Sensor needle would not retract and detach from the sensor inserter after deployed into skin.This has happened multiple times now and happened two times in a row, 1x on (b)(6) 2020 and took a break since it hurt and caused bruising/ripped tissue.Same thing happened on (b)(6).Have contacted company and they have not done anything other than send out new ones.Devices should be recalled and new ones should be issued.Device on (b)(6) 2020 failed and also did not have a wire in the sensor to go under the skin.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: 10852048
• MDR Text Key: 216915681
• Report Number: MW5097927
• Device Sequence Number: 2
• Product Code: MDS
• 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: 11/12/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 7273649
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 57