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

Model Number 9500-27

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

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Reaction (2414)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.Labeling indicates: 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) 2017, 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 located on the underneath the adhesive and was described as red, slightly swollen and hurting.The patient stated that the reactions to insertion sites have been occurring long before the dexcom system and that she has not discussed the dexcom system specifically with her doctor until (b)(6) 2017.On (b)(6) 2017 the patient told her doctor that the reactions are much better than they were with other systems.The doctor is not sure why the patient is having reactions.The patient stated that the doctor recommended an insertion sites other than the abdomen.The doctor did not make any other recommendations at that time.At the time of contact, the patient was well.No additional event or patient information was provided.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINOUS 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: 6386376
• MDR Text Key: 69323190
• Report Number: 3004753838-2017-15880
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• 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: 02/09/2017
• 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: 52 YR
• Patient Weight: 64