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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM CGM SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bruise/Contusion (1754); Rash (2033); Skin Inflammation (2443)
Event Date 07/01/2020
Event Type  malfunction  
Event Description
Reporter has skin inflammation, rash, and bruising from using four of his dexcom g6 cgm sensors. Reporter has contacted the manufacturer and has been sent one replacement sensor. The manufacturer has suggested to the reporter that he tries the suggestions for skin inflammation relief on their website. Reporter has tried several of the suggestions and none of them gave him any relief. He continues to have skin irritation and plans to call dexcom again today.
 
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Brand NameDEXCOM CGM SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10521256
MDR Text Key206945053
Report NumberMW5096559
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 09/10/2020
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
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: 09/10/2020 Patient Sequence Number: 1
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