MAUDE Adverse Event Report: DEXCOM G5 GLUCOSE MONITORING SYSTEM; SENSOR, GLUCOSE, INVASIVE

Model Number SW10611

Device Problems Application Program Problem (2880); Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2018

Event Type  malfunction  

Event Description

I use the dexcom g5 continuous glucose sensor and the mobile app for ios.After updating to the most recent version of the ios app the application failed to allow me to enter my initial calibration blood glucose level.The green submit button was missing from the calibration screen.I contacted dexcom on (b)(6) 2018 at 0906 am and spoke with (b)(4) in technical support.(b)(4) advised this is a known issue.Dexcom did not notify their users of this known issue that put users at risk.

• Brand Name: G5 GLUCOSE MONITORING SYSTEM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 7316878
• MDR Text Key: 101839914
• Report Number: MW5075689
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2018
• Device Model Number: SW10611
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 61