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U.S. Department of Health and Human Services

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

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DEXCOM, INC. SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/24/2020
Event Type  Injury  
Event Description
Using the dexcom g6 cgm. When the applicator attached the sensor, the sensor wire was completely injected into my upper arm and detached from the sensor. The sensor wire was left embedded under my skin and wasn't retrievable. It remains in my arm. Fda safety report id # (b)(4).
 
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Brand NameSENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11737384
MDR Text Key248175609
Report NumberMW5101021
Device Sequence Number2
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 04/23/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received04/27/2021
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

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