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

Model Number G6

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917)

Patient Problem Hyperglycemia (1905)

Event Date 12/18/2021

Event Type  Injury  

Event Description

I got alarms stating i would receive no readings.Give it up to 3 hours to come back.This happened for up to 20 minutes at a time a number of times throughout the night and next day.It went off at 11:30pm last evening, then back on at 12:30am this morning.I thought it was going to be ok, so did not change it.Changing it requires a 2 hour start up, and that leaves no readings, no pump suspension during that time.I do have night time low blood sugars.This morning, the cgm determined i was approaching a severe low, and suspended my pump.In actuality, based on a finger stick by an accurate meter (roche accucheck guide), my blood sugar was 176.The pump suspended, meaning my blood sugar went even higher.At 4:43pm, the same thing happened.I was in the 150s per finger stick, 'low' according to the cgm.This is the fourth sensor failure in as many applications.When a life is dependent on the device, it needs to work properly.I also filed a prior report for this same reason, last year.I am a registered nurse, certified diabetes educator and used to teach people how to use dexcom.It is not user error.I have photos of the discrepancy if needed.Thank you.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 13061475
• MDR Text Key: 282743878
• Report Number: MW5106223
• 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: 12/19/2021
• 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: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Model Number: G6
• Device Lot Number: 7290476
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2021
• Patient Sequence Number: 1
• Treatment: DEXCOM G6 CONTINUOUS GLUCOSE METER; TANDEM BASAL IQ INSULIN PUMP
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White