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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Incorrect, Inadequate or Imprecise Resultor 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).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12843874
MDR Text Key281082219
Report NumberMW5105461
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received11/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 11/18/2021 Patient Sequence Number: 1
Treatment
DEXCOM; FLUDROCORTISONE; HYDROCORTISONE ; NOVOLOG; OMNIPOD
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