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

Model Number G6 SENSOR

Device Problems Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); Skin Irritation (2076)

Event Date 01/17/2021

Event Type  malfunction  

Event Description

Two separate failures of dexcom g6 sensor inserter from same lot number.In both cases, the sensor inserter/applicator device failed to retract the sensor insertion needle after having pressed the orange deploy button as instructed.The needle remained inserted in my skin and the inserter device would not disconnect from the plastic sensor body.I pressed the deploy button several more times but was unable to get the needle to retract/device to detach.I was forced to carefully remove the entire system from my skin with needle deployed.This led to bleeding due to the needle being forcefully removed (which is inserted at a 45 degree angle) and skin irritation due to having to remove the adhesive patch which had just been applied to skin using skintac adhesive promoter.I attempted to insert a second new sensor some time later the same day and the same incident happened again.Needle did not retract.Applicator would not detach from sensor body.Both sensors were from the same 3-pack of lot number 5278761.I have experienced the same malfunction once before (unreported) during 2020.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: 11207505
• MDR Text Key: 228471923
• Report Number: MW5098921
• 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: 01/18/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/12/2021
• Device Model Number: G6 SENSOR
• Device Catalogue Number: STS-OR-003
• Device Lot Number: 5278761
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 73