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U.S. Department of Health and Human Services

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

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DEXCOM, INC DEXCOM G6 CGM SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)
Event Date 04/07/2021
Event Type  Injury  
Event Description
Continuous rashes; dexcom launched a new platform g6 last year. The tape on the sensors gives me terrible systemic allergic skin reactions. Using the device requires me to use two barrier films to prevent rash and hive breakout, plus flonase and benedryl. It's supposed to help me as a medical device but the vendor will only take reports and provide replacements. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 CGM SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC
MDR Report Key11648166
MDR Text Key245170005
Report NumberMW5100696
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 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberG6
Device Catalogue Number9500-43
Device Lot Number7279536
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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: 04/09/2021 Patient Sequence Number: 1
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