MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSE DIABETES MANAGEM

Model Number G6

Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)

Patient Problem Pain (1994)

Event Date 01/11/2020

Event Type  Injury  

Event Description

Dexcom g6 continuous glucose monitor insertion device failed.The insertion tool failed to retract the needle upon pressing the insertion button.The needle was stuck under the skin (but also attached to the skin with adhesive).Had to use a large wooden spoon to whack the back of the insertion device very hard several times in order to get the needle to retract from skin.This happened three times with three different sensors from the same lot number.It was very painful and if we had heard about others who had the same issue using the ¿wooden spoon trick¿, we likely would have to peel the sensor off while the needle was still stuck in her skin, resulting in more bleeding.This problem has affected many users.Many users are now including wooden spoons in their children¿s ¿emergency diabetes kits¿ along with their g6 sensors in case it happens at school or on the road.My daughter worries every time we change sensors that they will get stuck again.This should not be a concern we deal with¿the product should work properly every time.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSE DIABETES MANAGEM
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 9622874
• MDR Text Key: 176435954
• Report Number: MW5092457
• Device Sequence Number: 1
• Product Code: QDK
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/18/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: G6
• Device Lot Number: 7266524
• 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): Required Intervention
• Patient Age: 3.5 YR
• Patient Weight: 16