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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CONTINUAL GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problems False Alarm (1013); Low Readings (2460); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Hyperglycemia (1905)
Event Date 08/01/2021
Event Type  Injury  
Event Description
I was on an offshore fishing trip, 50 miles out in the (b)(6), we left the dock at 7am with plans not to return until 5pm. I was assured about the dependability of the g6, so i did not bring an additional blood sugar meter with me, the g6 should be dependable for less than 24 hours. I did have glucose and snacks with carbs in case a low did occur (and of course short term acting insulin). After the 2 hour boat ride out to the fishing grounds, we had begun to fish. About 20 minutes into it, i began to receive low blood sugar alerts from the g6 unit. As there was no previous experience to distrust the information, i took appropriate action for a type 1 diabetic experiencing a low blood sugar. At that time, the sensor was on only day 4 of the 10 day lifespan, and everything was in place as it should. At that time there was no reason to suspect any sort of failure or mis-reading by the g6 system. These alerts would last for more than 3 hours, and after consuming all the "emergency sugars" i had brought with me. Because of the information i was receiving from the g6 system, i was forced to inform the captain of my medical need to return to port. About half way home, a person onboard remembered they had an additional blood sugar monitor available. Upon testing my blood sugar, it displayed 374. All the while i was still receiving urgent low blood sugar alerts. The g6 unit prior to sunday (b)(6) 2021, had been operating correctly and as advertised. Original insertion of the sensor on (b)(6). (well within the 10 day limit for usage. ) i have no apparent cause for why this failure occurred, nor does dexcom. My phone, the acting receiver, was in a cool dry location, and the g6 unit was under clothing and never exposed to any direct sunlight or even submerged at any time. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CONTINUAL GLUCOSE MONITOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12276503
MDR Text Key265572997
Report NumberMW5102993
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/07/2021
Device Model NumberG6
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/03/2021 Patient Sequence Number: 1
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