MAUDE Adverse Event Report: DEXCOM, INC. T:SLIM G4 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 9500-27

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Rash (2033); Reaction (2414); Fluid Discharge (2686)

Event Date 03/31/2017

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 (b)(6) 2017 that on (b)(6) 2017, the patient experienced a skin reaction.The sensor was inserted on (b)(6) 2017.Patient reported that two days after putting the sensor on, they noticed a skin rash started to show from under the edge of the adhesive pad.At that point, the skin was painful to the touch and the patient removed the sensor.Additionally, the patient described the reaction as red, raised and leaking a clear liquid.It was also stated that the rash looked like a burn.The patient was seen by her physician, but date of the visit is unknown.The physician prescribed a topical cream for one of the rashes but the patient was unsure of the name of the prescription.On (b)(6) 2017, additional information was received from the patient.The patient reported that she had been wearing the dexcom system for six months with no skin irritations.There is no exact dates given for her initial skin reaction onset.The patient started experiencing skin irritations at her sensor site that initially would start after 3-5 days of wearing the dexcom system.The irritations would then start to progress within 24 hours after the sensor application.The patient indicated that the irritations were like an itchy rash with the appearance of clear discharge at the site where the sensor was removed.After the sensor removal, which was at times longer than 7 days of wear, the site of irritation would take a long period of time to heal (there is no specific time period stated) and she would place the sensor on another site other than her abdomen.The patient described her skin as sensitive and has other adhesive skin irritations at times, especially after running or times of perspiration.The patient had taken a break from wearing her sensors but recently restarted the use of sensors after learning of the new adhesive.The patient also reported the use of flonase at the sensor site and was going to try other physical barriers.At the time of contact, the patient was doing fine.No additional patient or event information was provided.

• Brand Name: T:SLIM G4 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: 6572741
• MDR Text Key: 75361017
• Report Number: 3004753838-2017-37429
• Device Sequence Number: 1
• Product Code: OYC
• 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: P140015
• 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: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/17/2017
• 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: 34 YR