MAUDE Adverse Event Report: DEXCOM G6 TRANSMITTER FOR CONTINUOUS GLUCOSE MONITORING SYSTEM; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MGMT

Model Number G6

Device Problem Output Problem (3005)

Patient Problem Hyperglycemia (1905)

Event Date 09/10/2019

Event Type  Injury  

Event Description

I am a (b)(6) y/o type i diabetic, a condition i've had since age (b)(6).I use both a tandem slim insulin pump, along with dexcom g6 sensors and transmitter.On september 10, 2019 through an email and phone call, i reported to dexcom that i was having difficulty having my usual 90 day re-supply order of its g6 sensors and transmitter (in its continuous glucose monitoring systems) filled.I eventually received my supply on september 17.But then problems with several transmitters began to occur.My sensor / transmitter linked wirelessly to my tandem t-slim pump began to show that the new transmitters were failing because its battery was low and must be replaced soon.I contacted dexcom again, and was told i was not eligible for a new supply of any sensors or transmitters until december 2019.As of september 27, and four replacement transmitters later, i have not been able to use the dexcom product because of transmitter failures - three transmitter failures to be specific, all of which render the product useless.Each time dexcom shipped me a replacement transmitter, they termed it "complimentary".I am now checking with my insurer (b)(6) of (b)(6) - to see if dexcom is billing my insurer for failed medical devices.I believe the mfr has not taken steps to either admit to or correct the problem with its g6 transmitters.Elevated blood sugars.Fda safety report id# (b)(4).

• Brand Name: G6 TRANSMITTER FOR CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MGMT
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 9145150
• MDR Text Key: 161178125
• Report Number: MW5090129
• Device Sequence Number: 2
• 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
• Type of Report: Initial
• Report Date: 09/28/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 66 YR
• Patient Weight: 88