MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; CONTINOUS GLUCOSE MONITOR

Model Number 9500-27

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Swelling (2091)

Event Date 06/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Labeling indicates: inserting the sensor and waring the adhesive patch might cause infection, bleeding, pain or skin irritations (e.G., redness, swelling, bruising, itching, scarring or skin discoloration).

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2016, the patient experienced a skin reaction.The sensor was inserted into the abdomen on (b)(6) 2016.The reaction was located on the abdomen and was described as itching, red bumps, puss and swelling.The patient stated that she thought the use of tegaderm was causing the irritation and switched to another off brand which still did not stop the irritation.It was stated that the patient is using over the counter (otc) hydrocortisone and otc benadryl to treat the affected areas.On (b)(6) 2016, patient went to the doctor to receive treatment for the irritation, but nothing was prescribed.At the time of contact, the patient was still experiencing irritation.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 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: 6321281
• MDR Text Key: 67086942
• Report Number: 3004753838-2017-10828
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 86