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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)
Event Date 01/28/2021
Event Type  Injury  
Event Description
Every time i wear my dexcom g6 blood glucose monitor, i get extreme itching, redness, and a rash that lasts for days after removal. This has been occurring for at least 6 months. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITOR
Type of DeviceINTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11272475
MDR Text Key230319223
Report NumberMW5099161
Device Sequence Number2
Product Code QBJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/30/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received02/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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

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