MAUDE Adverse Event Report: DEXCOM INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FACTORY CALIBRATED

Model Number G6

Device Problem Material Integrity Problem (2978)

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

Event Date 01/04/2019

Event Type  malfunction  

Event Description

I have recently started wearing the dexcom g6 continuous glucose monitor and noticed that its adhesive qualities are incredibly poor.It is supposed to be worn for 10 calendar days.However, the quality of the adhesion is so pathetically poor that it can barely make a 5 day wear mark.With the outrageous cost for insulin supplies and that fact that this product's ability to stay stuck in the skin is so poor, it's very concerning since the fda gave it a stamp of approval.

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM INC.
• MDR Report Key: 8228286
• MDR Text Key: 132568033
• Report Number: MW5082936
• Device Sequence Number: 1
• Product Code: QDK
• UDI-Device Identifier: 00386270000804
• UDI-Public: 00386270000804
• 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: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2019
• Device Model Number: G6
• Device Catalogue Number: 9500-45
• Device Lot Number: 5247402
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 113