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

Model Number 9500-27

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); Staphylococcus Aureus (2058); Reaction (2414)

Event Date 09/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dexcom g5 mobile continuous glucose monitoring system user's guide states: inserting the sensor and wearing 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 09/28/2016, that on (b)(6) 2016, the patient experienced a skin reaction.The sensor was inserted into the upper buttocks on (b)(6) 2016.The patient's mother stated that the patient developed a (b)(6) infection.On (b)(6) 2016, the patient's mother noticed that the patient had a 102 degree fever and redness with inflammation at the insertion site.Inflammation turned into an abcess and the patient was taken to the pediatrician.The infected area was lanced and drained.Testing came back positive for (b)(6) infection and the patient was prescribed a sulfamethoxazole and trimethoprim suspension.At the time of contact, the patient was still experiencing inflammation and was scheduled for a follow-up with their doctor to see if the area required further draining.Additional event or patient information is not available.No product or data was returned for evaluation.The reported event of skin reaction could not be confirmed.A root cause could not be determined.Labeling indicates: the dexcom g5 mobile continuous glucose monitoring (cgm) system is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes.

• Brand Name: DEXCOM G5 MOBILE 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: 6055969
• MDR Text Key: 58353819
• Report Number: 3004753838-2016-80606
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5216095(17)170729
• 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: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/29/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-041
• Device Lot Number: 5216095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• 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
• Patient Age: 17 MO
• Patient Weight: 10