MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM 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	06/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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) 2016, that the patient experienced a skin reaction to the sensor.The sensor was inserted on the left side of the abdomen on (b)(6) 2016.After 4-5 hours of insertion, the site started to itch.After 1-2 days, the patient felt a burning feeling.After the 3rd day, the patient removed the sensor due to the skin reaction.The patient reported that she saw her certified diabetes educator (cde) for routine check-up on (b)(6) 2016 and mentioned skin reaction she had in (b)(6) 2016, which had scarring on her abdominal area due to the reaction.Her cde recommended she insert the sensors in arm instead.The affected area was treated with over the counter products, hydrocodone cream, burn cream, liquid benadryl, benadryl cream, aveeno eczema cream, and coconut oil.At time of the contact, the patient was still having the same issues.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 G4 PLATINUM 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: 6355146
• Report Number: 3004753838-2017-10978
• Device Sequence Number: 720218
• Product Code: MDS
• UDI-Device Identifier: 10386270000016
• UDI-Public: (01)10386270000016(241)9500-27(10)NI(17)NI
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/26/2017

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 Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/23/2017
• 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: 51 YR
• Patient Weight: 61