MAUDE Adverse Event Report: DEXCOM DEXCOM G5; CONTINUOUS GLUCOSE MONITOR

Model Number G5

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Injury (2348); No Code Available (3191)

Event Date 04/24/2017

Event Type  Injury  

Event Description

Patient developed a nodule/sore at the site of dexcom sensor insertion, after sensor was removed.Initially small, non-painful module; evolved over 4 weeks into tender, larger nodular area.Ultrasound showed fluid collection, which was surgically drained on (b)(6) 2017.Wound culture send from drainage, which today grew mycobacterium, with speciation pending.Patient is otherwise healthy type 1 diabetic, also with celiac disease, who is in relatively good control of diabetes (hba1c typically between 7 - 8 percent).Was not using dexcom for longer than prescribed (i.E., was not keeping in longer than 7d).Called dexcom, who asked me to have patient call them but otherwise did not want to take a report.

• Brand Name: DEXCOM G5
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 6540489
• MDR Text Key: 74399117
• Report Number: MW5069504
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: G5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: INSULIN INJECTIONS (LANTUS AND RAPID-ACTING)
• Patient Age: 10 YR