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

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 It was reported that the patient was withdrawn from all further study procedures as it appears they exhibit skin reactions similar to an allergic reaction from the sensor adhesive, not just the sensor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).

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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 Key: 5467589
• MDR Text Key: 39271910
• Report Number: 3004753838-2016-01349
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• 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 Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 9500-27
• Device Catalogue Number: STS-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 Received: 02/03/2016
• 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