MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 9500-45

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a needle retraction issue occurred.The sensor was inserted into the upper buttocks on (b)(6) 2018.No product was provided for evaluation.Confirmation of the problem and probable cause could not be determined.No additional event or patient information is available.

Manufacturer Narrative

(b)(4).

Event Description

A sensor was returned for evaluation.The device was visually inspected and found that the applicator had excess friction, causing the drive wheel to not finish deployment as designed.The reported event of a needle retraction issue was confirmed.The probable cause determined to be excess friction.

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8155381
• MDR Text Key: 130329431
• Report Number: 3004753838-2018-155388
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: 00386270000255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2019
• Device Model Number: 9500-45
• Device Catalogue Number: STS-OR-001
• Device Lot Number: 5239999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2018
• 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 Age: 13 YR
• Patient Weight: 54