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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
Catalog Number SIS 0E 003
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Calibration Problem (2890)
Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)
Event Date 02/01/2021
Event Type  Injury  
Event Description
Rash / inflammation; dexcom g6 sensor adhesive now causing rash, skin discoloration, uncontrollable itching at any application site, including stomach and arms. Interferes with accurate readings of blood sugar and requires daily and multiple calibrations. 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 Key11495205
MDR Text Key240403227
Report NumberMW5100006
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/11/2021
Device Catalogue NumberSIS 0E 003
Device Lot Number7283088
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: 03/15/2021 Patient Sequence Number: 1
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