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

Model Number G6

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Hypoglycemia (1912)

Event Date 02/21/2021

Event Type  Injury  

Event Description

Undetected hypoglycemia; continuous glucose meter displays 'sensor error' and does not communicate with the insulin pump that is supposed to suspend insulin delivery when there is a predicted low blood sugar.This has happened with 9 of 10 sensors.This last one went bad before receiving the replacement of the previous one that went bad.The replacements are also not working correctly.This can be a life or death situation when dealing with a low blood sugar.I have photos of the gaps in cgm-pump/phone communication.I also have a photo of my pump being suspended when no communication was received from undetected.When calling dexcom for the problem, i have always been referred to tandem (my pump company) for replacement of the malfunctioning sensor.Dexcom is not taking ownership of the problem, and nothing has been done to correct it.Fda safety report # (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE METER
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11372256
• MDR Text Key: 233555657
• Report Number: MW5099578
• Device Sequence Number: 6
• 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: 02/21/2021
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/24/2021
• Device Model Number: G6
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 82