MAUDE Adverse Event Report: DEXCOM, INC. TRANSMITTER; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Model Number G6

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  Injury  

Event Description

First, dexcom has multiple problems with the g6 system.If you look at the fb group you will see a plethora of failures happening daily.This seems to fall within the warranty of merchantability.Today's problem is 2 fold; failed transmitter and failed sensor.Installed a new transmitter and sensor today.Initially the sensor failed to retain the transmitter which rendered the sensor useless.After replacing the sensor the new transmitter won't connect via bluetooth.I tried all conventional bluetooth resolutions but none fixed the problem.This product (g6) needs to have a recall issued until potentially life threatening problems are resolved.Fda safety report id # (b)(4).

• Brand Name: TRANSMITTER
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12532664
• MDR Text Key: 273648550
• Report Number: MW5104208
• Device Sequence Number: 2
• Product Code: QBJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/11/2022
• Device Model Number: G6
• Device Lot Number: 5293710
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening