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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Peeling (1999); Skin Irritation (2076); Discharge (2225); Discomfort (2330)
Event Date 02/01/2020
Event Type  Injury  
Event Description
Caller is reporting on the dexcom g6 10 days sensors. She has been using the device for years and follows the instructions on applying the device. She alleges that after 5 hours of replacing a sensor, she experienced an irritation which was unbearable and the area began to itch terribly this caused her to scratch the area due to the discomfort. The area became reddened and was weeping, making the area wet and causing the device to fall off. This leaves her skin peeled, irritated and infected. Caller states "there is a rash making the area feel like sand paper". Caller advised she has notified the manufacturer and has emailed pictures of the scarring and all they do is replace sensors and recommend using skin preps you have to buy for (b)(6). Caller is on (b)(6) and can not afford any extra expense. She states "my arm got so infected i missed 3 days of work". Caller wants the fda to look into this as many other users are suffering. She is part of a (b)(6) group who are looking into pursuing a class action lawsuit against the manufacturer. Caller advised the scarring on her body is terrible and its affecting her self confidence as she is hiding her body from her partner and covering up with long sleeves in hot weather. She states she is disfigured from using the device. Caller estimates this issue has occurred over 30 times beginning (b)(6) of this year and something needs to be done.
 
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Brand NameDEXCOM G6 SENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10390370
MDR Text Key202608176
Report NumberMW5095993
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 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
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

Patient Treatment Data
Date Received: 08/10/2020 Patient Sequence Number: 1
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