MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM 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 Purulent Discharge (1812); Erythema (1840); Itching Sensation (1943); Reaction (2414); Skin Inflammation (2443)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dexcom g4 mobile platinum 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 (b)(6) 2016 that the patient experienced a skin reaction on (b)(6) 2016.The sensor was inserted into the arm on (b)(6) 2016.Skin reaction was described as being raised, hive-like, itchy, blister-like and containing pus.Reaction was located on the arm under the sensor patch.On (b)(6) 2016 patient was seen by her doctor for the skin reaction.Date of doctor visit is an approximation.The patient was prescribed a 2% hydrocortisone cream.Affected area was treated with over-the-counter (b)(6) lotion that clears the itching.Additional event or patient information was not provided.No product or data was provided for evaluation.The reported event of skin reaction could not be confirmed.A root cause could not be determined.The sensor was inserted into the arm.Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).

• 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: 5900279
• MDR Text Key: 52874051
• Report Number: 3004753838-2016-80169
• 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: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• 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: 07/27/2016
• 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: OMNIPOD INSULIN PUMP
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 54