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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOMG6 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

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DEXCOM, INC. DEXCOMG6 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED Back to Search Results
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Rash (2033); Skin Irritation (2076)
Event Date 01/15/2020
Event Type  Injury  
Event Description
I have been using dexcom g6 sensor from around (b)(6) 2019 without any skin irritation or infection. Since dexcom has changed the sensor adhesive around (b)(6) 2019, i started experiencing severe skin rash and infection. I have contacted dexcom multiple times for alternate solutions and they weren't of any use and very reluctant to listen to the product problem. So far i have not received any updates from them. Fda safety report id# (b)(4).
 
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Brand NameDEXCOMG6
Type of DeviceINTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10465378
MDR Text Key204977858
Report NumberMW5096316
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/26/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
Device Lot Number527 4677
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: 08/27/2020 Patient Sequence Number: 1
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