MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 PRO; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR PROFESSIONAL DIRECTED RETROS

Model Number G6

Device Problem Battery Problem: Low Impedance (2973)

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

Event Date 08/25/2020

Event Type  malfunction  

Event Description

During morning the dexcom monitor alerted me that the transmitter battery "is critically low".I had to revert glucose readings via finger sticks.Called dexcom tech support and reported the problem.They assigned case # (b)(4); and then confirmed they would send replacement transmitter and sensor overnight.Real concern would be if this occurred during the night (might not hear the alert) or traveling (difficult to contact dexcom tech support).Dexcom only provides one (1) transmitter and this is to last twelve (12) weeks.This problem transmitter was installed (b)(6) 2020 and the battery failed (b)(6) 2020 or approximately 7 weeks.If your traveling you wouldn't have a spare transmitter and you may not have sufficient glucometer test strips to see you through to when a new transmitter could be provided.

• Brand Name: DEXCOM G6 PRO
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR PROFESSIONAL DIRECTED RETROS
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10493899
• MDR Text Key: 205915727
• Report Number: MW5096432
• Device Sequence Number: 1
• Product Code: QII
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2020
• Device Model Number: G6
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 79