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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
Model Number DEXCOM G6 SENSOR
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Pain (1994); Skin Irritation (2076); Blood Loss (2597)
Event Date 07/25/2020
Event Type  Injury  
Event Description
I am using a dexcom g6 cgms and have been for six months. I keep developing a skin reaction to the sensor that includes itching, painful irritation and occasional bleeding. 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 Key10343641
MDR Text Key201198570
Report NumberMW5095787
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
Type of Report Initial
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/25/2021
Device Model NumberDEXCOM G6 SENSOR
Device Catalogue NumberSTS-OM-003
Device Lot Number7275603
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: 07/29/2020 Patient Sequence Number: 1
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