MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	9500-27
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Rash (2033); Reaction (2414)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The g5 system is associated with product code pqf.The dexcom g5 mobile continuous glucose monitoring system user guide states: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e.G., redness, swelling, bruising, itching, scaring or skin discoloration).
Event or Problem Description
Dexcom was made aware of 01/28/2017, that on (b)(6) 2017, that the patient experienced a skin reaction to the sensor.The sensor was inserted on the abdomen on (b)(6) 2017.The patient stated that upon insertion, the site immediately started itching.Later that day, the patient complained that the site itched and the patient's mother noticed little bumps around the adhesive.On (b)(6) 2017, the patient's mother removed the sensor to discover the skin reaction which was red, warm, and has little bumps around the sensor insertion site.The reaction was a quarter sized.The patient's mother called the doctor and was prescribed steroid cream.At the time of contact, the patient was doing fine.Additional event or patient information is not available.No product or data was provided for evaluation, however a photograph was provided.The reported event was confirmed through the photograph.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 6358820
• Report Number: 3004753838-2017-10982
• Device Sequence Number: 1656293
• Product Code: MDS
• UDI-Device Identifier: 10386270000016
• UDI-Public: (01)10386270000016(241)9500-27(10)5219865(17)171007
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/07/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5219865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2017
• Initial Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 YR
• Patient Weight: 30