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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Catalog Number PN: 9500-45
Device Problems Difficult to Remove (1528); Retraction Problem (1536)
Patient Problems Pain (1994); Scar Tissue (2060)
Event Date 02/18/2021
Event Type  Injury  
Event Description
Bodily injury; this device's applicator is intended to insert a sensor thread into the body, by inserting and immediately retracting a needle, and releasing the sensor from the applicator and attaching sensor to body. During this malfunction, the needle did not retract, and the applicator did not release its sensor. To remove sensor and applicator from my body, i ripped sensor from my body while holding the applicator. This caused needle to tear out of my body, which resulted in much pain and physical scars. Two similar incidents occurred on (b)(6) 2019, which was reported to your office on form 3500b (access number mw5091501), and on (b)(6) 2021, which was also reported to your office on form 3500b (access number not yet provided to me). I began using dexcom's g6 about two years ago. Based on four incidents on (b)(6) 2019, (b)(6) 2021, and two on (b)(6) 2021, i do not consider this device safe. Each device is intended for a lifespan of 10 days of use. However, in recent years its quality has deteriorated. Most sensors do not function reliably between the seven and 10 day lifespan. I do not consider this device effective after seven days of use. Dexcom (manufacture) did not recall the lot numbers, and was unwilling to issue a product recall when i contacted them. I have experienced four product malfunctions - two on the sale day. When will the fda require a product recall?. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11776406
MDR Text Key249730417
Report NumberMW5101148
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 04/30/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received05/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/15/2021
Device Catalogue NumberPN: 9500-45
Device Lot Number7282165
Was Device Available for Evaluation? No
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: 05/04/2021 Patient Sequence Number: 1
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