MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE 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 Purulent Discharge (1812); Erythema (1840); Reaction (2414); Skin Inflammation (2443)

Event Date 06/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dexcom g4 platinum continuous glucose monitoring system user's guide states: inserting the sensor and waring the adhesive patch might cause infection, bleeding, pain or skin irritating (e.G.,redness, swelling, bruising, itching, scarring or skin discoloration).

Event Description

Patient's mother contacted dexcom on (b)(6) 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 she had removed the sensor at the end of seven days and saw the reaction located underneath the sensor where the sensor wire was inserted.The reaction was described as having yellow pus at needle insertion site, around that was an inflamed circle with tiny red circles around the big red circle.Patient's mother took patient to urgent care due to the skin reaction and was prescribed antibiotic sulfamethoxazole.Patient's mother does not remember the exact date in which they went to urgent care, she stated it was sometime between (b)(6) 2016.At the time of contact, the patient was well.No additional event or patient information was provided.The sensor was inserted into the arm.The dexcom g5 mobile continuous glucose monitoring system states: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites.If placed in other areas, the dexcom g5 mobile system may not function properly.

• Brand Name: DEXCOM G5 MOBILE 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: 5764109
• MDR Text Key: 48613536
• Report Number: 3004753838-2016-03634
• 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: 06/07/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2015
• 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