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

Device Problems Product Quality Problem (1506); Low Readings (2460)

Patient Problem Hyperglycemia (1905)

Event Date 04/15/2022

Event Type  malfunction  

Event Description

I have been using dexcom g6 for 2 years now.They say you don't need to do finger sticks.Well, i found i need to calibrate at least 2 to 3 times a day.Dexcom says i'm 50 to a 120 points off from a finger stick most of the time.When i tried bringing it to their attention they brush me off.This morning dexcom read 123 and i did a finger stick and i got a reading of 223.I did have dka back in 2020.So this is serious as i could have gone into dka again due to false readings.My doctors are aware of the issue.But not sure if they have reported it.I'm tired of the issue happening over and over.It doesn't matter if i change sensors or transmitters.It still happens.I feel they are being deceptive.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG
• Manufacturer (Section D): DEXCOM INC
• MDR Report Key: 14160445
• MDR Text Key: 289779744
• Report Number: MW5109156
• Device Sequence Number: 1
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/13/2022
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American, White, American Indian Or Alaskan Native