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

Model Number 9500-27

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Skin Inflammation (2443)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient's mother contacted dexcom on (b)(6) 2016, to report a skin reaction that occurred on (b)(6) 2015.Sensor was inserted at the buttocks on (b)(6) 2015.Patient's mother reported that the patient's skin is very red, bloody looking and swollen below the adhesive patch.Itchiness starts very quickly and after 2 days of use, the skin surface looks bloody.Patient started having skin reactions after 10 months of use.Patient's mother treats the affected area with fougera triamcinolone cream, prescribed by patient's physician in (b)(6) 2015.An exact date of medical intervention and prescription is unknown.Additionally, patient's mother treats the skin with johnson and johnson's tough pads and tegaderm.Currently, patient's mother has moved sensor insertions to the patient's leg to allow other areas to heal.No additional event or patient information is available.It should be noted that the dexcom g4 platinum continuous glucose monitoring system users 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).Additionally, it should be noted that the dexcom g4 platinum (pediatric) continuous glucose monitoring system is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego 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: 5399655
• MDR Text Key: 37159466
• Report Number: 3004753838-2016-00797
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• 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: 01/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ANIMAS VIBE INSULIN PUMP
• Patient Outcome(s): Other
• Patient Age: 19 MO
• Patient Weight: 11