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

Model Number 9500-27

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

Patient Problems Itching Sensation (1943); Scarring (2061); Burning Sensation (2146); Reaction (2414)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Labeling indicates: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration).The g5 system is associated with product code pqf.

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the patient experienced a skin reaction.Date of issue is an approximation.Sensor was inserted into the abdomen on (b)(6) 2017.Patient stated that they developed burning and an itching sensation approximately 2-3 days after sensor insertion and after day 7, scarring developed.Reaction extended outside the area where the sensor patch was adhered to the skin.The affected area was treated with over-the-counter neosporin.Dexcom made further contact with the patient on 04/27/2017.The patient reported that she has been using dexcom for approximately 1 year and after 6 months of sensor placement, began to experience redness and itching, which would begin on about day 3 of sensor wear.After sensor removal, the skin would often appear raw and exposed.Patient reported that subsequent dexcom applications skin irritation increased in intensity and the onset of symptoms would occur within one day of sensor insertion.The patient has used over-the-counter neosporin to treat the reactions and had not seen a physician.The patient has also tried tegaderm and tough pads as skin barriers, with only a limited decrease in itching and burning.Patient indicated that they stopped using the dexcom system for an unspecified time.At the time of contact, the patient was in good condition.No additional event or patient information is available.

• 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: 6558544
• MDR Text Key: 74863196
• Report Number: 3004753838-2017-40267
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2017
• 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: 47 YR