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

Model Number 9500-44

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

Patient Problems Erythema (1840); Itching Sensation (1943); Burning Sensation (2146); Reaction (2414)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The user's 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).

Event Description

Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, that the patient experienced a skin reaction underneath the sensor.The sensor was inserted on (b)(6) 2016.The reaction was described as itchy, red, burning, and prickly.Affected are was treated with a moisturizer, and penicillin which was prescribed on (b)(6) 2016.At the time of contact patient is fine.No additional event or patient information is available.No product or data was provided for evaluation.The customer complaint could not be confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4) describe event or problem - correction to statement "no product or data was provided for evaluation.The customer complaint could not be confirmed.A root cause could not be determined." if follow-up, what type?: additional information/correction, event problem and evaluation codes - additional.

Event Description

Product was not provided for investigation.However, photographs were provided which confirmed the reported event of a skin reaction.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS 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 ; 8585000200
• MDR Report Key: 5998651
• MDR Text Key: 56443428
• Report Number: 3004753838-2016-22785
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 14 YR