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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-27
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Skin Inflammation (2443)
Event Date 02/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Study coordinator contacted dexcom on (b)(6) 2016, to report on behalf of a study patient that a suspected adhesive reaction occurred on (b)(6) 2016. Sensor was inserted at the abdomen on (b)(6) 2016. It was reported that the original sensor insertion site did not fully dissipate. Patient initially experienced itching at sensor insertion site. When the sensor was removed at the clinic, the patient had significant redness with a rating of 3 on the draize scale for erythema. The patient has been treating the affected area with hydrocortisone 1% cream, 2-3 times per day. It was reported that the patient was withdrawn from all further study procedures as it appears they exhibit skin reactions similar to an allergic reaction from the sensor adhesive, not just the sensor overlay. No additional event or patient information is available. It should be noted that the dexcom g4 platinum continuous glucose monitoring system users guide states: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring, or skin discoloration).
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key5467589
MDR Text Key39271910
Report Number3004753838-2016-01349
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,study
Reporter Occupation
Type of Report Initial
Report Date 02/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/29/2016 Patient Sequence Number: 1
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