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

Model Number 9500-35

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 12/22/2016

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 02/16/2017 that on (b)(6) 2016, that the patient experienced a skin reaction.Date of event is an approximation.The distributor reported the reaction description as large redness, burning, itchy sensation, and contact allergy.The patient stopped using the device due to the contact allergy.The party reporting to the distributor on behalf of patient alleged that the sensor patch contains a substance that causes the allergy.The patient had an allergy patch test conducted in (b)(6) of 2017.It was found that the patient tested positive for reaction to the adhesive and therefore, it was concluded that the adhesive contains a substance that induces contact allergy.No additional patient or event information was provided.No product or data were provided for evaluation.The reported event could not be confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

• 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 ; 8582000200
• MDR Report Key: 6401462
• MDR Text Key: 69839110
• Report Number: 3004753838-2017-02498
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2017
• Device Model Number: 9500-35
• Device Catalogue Number: STS-GL-006
• Device Lot Number: 5209728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2016
• 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