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U.S. Department of Health and Human Services

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

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DEXCOM, INC. SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Battery Problem (2885); Communication or Transmission Problem (2896)
Patient Problem Insufficient Information (4580)
Event Date 12/20/2020
Event Type  malfunction  
Event Description
A reporter called to report that he is having issues with his dexcom g6 glucose monitor and sensors. He said the monitor is not communicating with the sensors as a result it is not doing what it is supposed to do. He said sometimes the battery shuts down and the sensors only lasts for 2-1/2 to 3 days instead of the 10 days. He contacted dexcom every time he was encountering problems, however, they just keep sending him a replacement instead of addressing the issues. He said so far he had 8 or 9 replacements.
 
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Brand NameSENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11261931
MDR Text Key230091571
Report NumberMW5099125
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 01/29/2021
10 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9   10  
0 Patients were Involved in the Event:
Date FDA Received01/29/2021
Is this an Adverse Event Report? No
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

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