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 Bacterial Infection (1735); Burn(s) (1757); Itching Sensation (1943); Rash (2033)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dexcom g4 platinum 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

Patient's mother contacted dexcom on 06/15/2016 to report that the patient experienced a skin reaction on (b)(6) 2016.The sensor was inserted into the arm on (b)(6) 2016.Patient's mother stated that the reaction was an itchy rash that looked like the skin was burnt.Reaction was located on the back of the patient's arm.On (b)(6) 2016 the patient's mother took the patient to the urgent care and an additional clinic.The patient was seen for a bacterial infection on her arm, caused by the sensor.The patient was prescribed oral antibiotics to be taken for 10 days.Patient completed the prescription therapy.At the time of contact, the patient's bacterial infection had cleared.No additional event information was provided.The sensor was inserted into the arm.The dexcom g4 platinum with share (pediatric) user's guide states: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks.Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, the patients mother contacted dexcom on 06/21/2016 to provide additional information regarding the patients prescribed medication.The patient was prescribed 350ml of bactrim that was taken 2 times a day for 10 days, as well as bactroban ointment which was applied 2 times a day for 7 days.No further event or patient information is available.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5797322
• MDR Text Key: 49620227
• Report Number: 3004753838-2016-38713
• 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,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• 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: 06/21/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 6 YR