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

Model Number 9500-45

Device Problem Component Missing (2306)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 11/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, upon removal of the sensor pod from the patient body, the sensor wire had detached. The sensor was inserted at the abdomen on (b)(6) 2016. Patient's father reported that the patient said the insertion was painful, and that the sensor didn't start the initialization process. After some minutes, blood was observed around the sensor patch. Patient's father took out the sensor and immediately noticed that it didn't have the sensor wire attached to the sensor pod. Patient's father informed his diabetologist who advised an x-ray exam. The x-ray exam confirmed that the sensor wire was left inside the patient's abdomen-left side. On (b)(6) 2016, a surgical procedure was performed that successfully removed the sensor wire pieces. Patient's father reported that the procedure was difficult and lasted three (3) hours. 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: 6139572
• MDR Text Key: 61289265
• Report Number: 3004753838-2016-53436
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9500-45
• Device Catalogue Number: STS-GF-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/11/2016
• 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 Treatment Data

Date Received: 12/01/2016 Patient Sequence Number: 1