MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6; SENSOR, GLUCOSE, INVASIVE

Model Number G6

Device Problems Low Test Results (2458); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Dexcom g6 continuous glucose monitor sensors.These have been failing well before the 10 day supposed life of the sensor.Also, readings can be far off, mostly very low ( i.E., reading of 40, when finger stick is 230.This is not just me - the forums have numerous citations similar to mine.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 13949716
• MDR Text Key: 288311675
• Report Number: MW5108611
• 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: Physician
• Type of Report: Initial
• Report Date: 03/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: G6
• Device Catalogue Number: 9500-45
• Device Lot Number: 5294748
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White