MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6; INTEGRATED CONTINUOUS MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAGEMENT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/19/2019

Event Type  malfunction  

Event Description

Dexcom g6 continuous glucose monitor showed reading of 43; actual glucose was 125.It auto-suspended my tandem t:slim insulin pump multiple times.Calibrated g6.Checked again in 15 mins, cgm showed glucose was 58; actual glucose was 181.Auto-suspended again.Then dexcom g6 would not accept a calibration at all.This was on day 8 of a 10 day sensor.Insulin pump auto-suspend.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAGEMENT
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 9219807
• MDR Text Key: 163574589
• Report Number: MW5090545
• Device Sequence Number: 1
• Product Code: QDK
• 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: 10/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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 Age: 49 YR
• Patient Weight: 72