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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
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Hypoglycemia (1912)
Event Date 12/30/2019
Event Type  Injury  
Event Description
Dexcom g6 sensor failure, resulted in hypoglycemia which required ambulance transport to ed, this makes eleven (11) sensor failures in the last twelve (12) months. Fda safety report id# (b)(4).
 
Event Description
Add'l info received from reporter on 12/31/2019 for report # mw5091947. Dexcom g6 sensor failure, resulted in hypoglycemia which required ambulance transport to ed, this makes thirteen (13) sensor failures in the last twelve (12) months. 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 Key9536111
MDR Text Key173235979
Report NumberMW5091947
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,Followup
Report Date 12/30/2019
13 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9   10   11   12   13  
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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: 12/31/2019 Patient Sequence Number: 1
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