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

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hyperglycemia (1905)

Event Date 11/16/2021

Event Type  Injury  

Event Description

My son uses the dexcom g6 system.I want to make the fda aware that the dexcom "no more fingersticks" line of advertising is erroneous and needs to stop.Even with the asterisk and fine print, it is still misleading.I'm very wellversed in using dexcom and have used it with my son for over a year.I have been trained on its use, read the product brochure, and spoken to dexcom representatives as well as diabetic consultants about it.Usually, the dexcom is correct within an order of magnitude (although the 20% allowable variance is not a particularly good selling point - sometimes that can mean the difference of a whole unit of insulin, which for a child can be quite a bit).Every few sensors, though, we have one that is so inexcusably far off the 20% allowable variance (just today, a sensor that had been right on the money for awhile, suddenly was reading 75 when two readings from a glucometer revealed he was in the 150s instead).Additionally, when you're dealing with children, hypo- and hyper-unawareness aren't unusual, and thus, the asterisk that says that fingersticks are required when symptoms don't match the number displayed doesn't encompass everything.I fingerstick my son once or twice a day to make sure the number matches the dexcom relatively well.This has rescued us more than once (for example, there was a night a few months ago that the dexcom read in the 160s and steady vs.Fingersticks reading in the 90s and steady).People have died from the "no fingersticks" line of advertising (b)(6).Please help prevent more of these situations.I'm aware of this technology's limitations because i'm zealous about protecting my son's health and well-being.Many diabetics aren't aware of these limitations.Please ask dexcom to change this line of advertising.Thank you, elizabeth dahlvang.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12843874
• MDR Text Key: 281082219
• Report Number: MW5105461
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 11/16/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: DEXCOM; FLUDROCORTISONE; HYDROCORTISONE ; NOVOLOG; OMNIPOD
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 39 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White