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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
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/08/2019
Event Type  Injury  
Event Description
Reporter called to report while attaching a sensor to her daughter's leg, her daughter started screaming, was pain, and began shaking. Two hours later, the sensor failed and the cannula was not attached. The area where the sensor was appeared red, raised, hot to touch, had a burning sensation and was not weight bearing. On (b)(6) 2019, the reporter took her daughter to the urgent care and after one hour of exploratory process, the wire cannula was unable to be found. The urgent care referred the reporter to a plastic surgeon. At the consultation, the dr did not want to try to explore the site for the wire cannula. But, instead treat with an antibiotic while waiting a week and a half for wire self expel. On (b)(6) 2019 multiple x-rays were taken to find the missing sensor wire cannula, which was found deep in the calf muscle. Surgery was completed for successful removal of the wire.
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key8785527
MDR Text Key151101336
Report NumberMW5088059
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 Family Member or Friend
Type of Report Initial
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 07/11/2019 Patient Sequence Number: 1
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