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

Lot Number 7273673

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 08/27/2020

Event Type  malfunction  

Event Description

I attempted to insert a dexcom g6 sensor - the needle failed to retract causing pain and rendering the sensor useless.I tried with another sensor, but the entire box of sensors was faulty.This left me without continuous glucose monitoring.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10477064
• MDR Text Key: 205336052
• Report Number: MW5096350
• Device Sequence Number: 1
• Product Code: MDS
• 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
• Type of Report: Initial
• Report Date: 08/27/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/26/2021
• Device Lot Number: 7273673
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 79