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

Model Number 9500-27

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

Patient Problems Erythema (1840); Itching Sensation (1943); Reaction (2414); Skin Inflammation (2443)

Event Date 02/06/2016

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

Dexcom was made aware on 09/12/2016, that on (b)(6) 2016, the patient experienced a skin reaction.The sensor was inserted into the abdomen on (b)(6) 2016.The reaction was described as red, inflamed, intense and itchy.Patient also stated that the reaction feels like something was eating the skin around the sensor wire.Patient indicated that the reaction was located directly around the sensor wire itself, and was not a reaction to the adhesive patch.At the time of contact, the patient had been experiencing the reaction for 6 months.Patient reported that after the first application of sensor, things were fine until about the 5th day of wearing it.Itching started and it became so intense that the patient took the sensor off.The described cycle persisted for some time but then the intensity of the itching increased and the duration of wearing the sensor decreased.The patient couldn't wear the sensor for as long as before and had to take the sensor out.As of the time the patient saw her endocrinologist, (b)(6) 2016, she could not wear the sensor for more than a day or two.The patient was not prescribed any medications during her appointment with the endocrinologist.Patient did not treat the affected area and stated that the symptoms abated within a day or two after the sensor was removed.Additionally, the patient reported that she has a history of skin sensitivities to metals.At the time of contact, the patient was fine.No further event or patient information is available.No product or data was returned for evaluation.The reported event of skin reaction could not be confirmed.A root cause could not be determined.

• 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: 6017725
• MDR Text Key: 57042929
• Report Number: 3004753838-2016-80470
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• 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: 09/12/2016
• 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: 33 YR