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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 GLUCOSE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 10/15/2021
Event Type  malfunction  
Event Description
Blood glucose raised; on (b)(6) 2021 at 1247, i inserted a new dexcom g6 sensor. I calibrated the sensor 3 times with values well over a 20% accuracy. All sensor values were low, with the lowest about 40. I was reading in the low 100s. The second sensor was inserted on (b)(6) 2021 at 0842 from the same box. Again, i had to calibrate 3 times with the sensor reading low again. 46 was the lowest value. The 3rd sensor came from a different box, with the same lot number. I did the exact same thing. On my third calibration, i was reading 111 on my glucometer, the sensor was at 73. Then, it was dropped to 51 after calibrating it for the third time. All the above readings were from the dexcom app. Tandem is apparently responsible for all dexcom sensor and transmitter issues, when the sensor/transmitter are ordered with the tandem tslim x2. Since, my first complaint against tandem, there have been technical questions about the actions with the pump that ignored by my endocrinologist and others were never explained in the book,m. On top of the fact, dexcom had no care about bad a sensor lot that might have concerns when i contacted. I wanted them to test the sensors but that request must come from tandem. It makes me curious why as to why i agreed to cgm. I don't like the idea that i'm being targeted because i filed statements to the fda. Further, if tandem had been forthcoming in the first user manual, i would never have believed there was a need to speak up as a user. Neglect is as bad as abuse. Trust me, i have been on both sides at the same time from different people. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 GLUCOSE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12665145
MDR Text Key277877975
Report NumberMW5104775
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 10/15/2021
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
Device Lot Number5290539
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: 10/19/2021 Patient Sequence Number: 1
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