MAUDE Adverse Event Report: DEXCOM INC. DEXCOM G6; INTEGRATED CONTINUOUS GLUCOSE MONITOR SYSTEM FOR NON-INTENSIVE DIABETES MANAGEME

Model Number G6

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 03/14/2019

Event Type  malfunction  

Event Description

Dexcom g6 doesn't work as advertised.Bg readings are well outside the acceptable range.Sensor patch falls off within 3-4 days of being applied.Sensor patches generally are wrinkled or damaged during the application process.This product is cheap and is a danger to t1d in the usa.

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITOR SYSTEM FOR NON-INTENSIVE DIABETES MANAGEME
• Manufacturer (Section D): DEXCOM INC.
• MDR Report Key: 8432518
• MDR Text Key: 139292606
• Report Number: MW5084988
• Device Sequence Number: 0
• Product Code: QDK
• 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: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/11/2019
• Device Model Number: G6
• Device Lot Number: 5246926
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR