MAUDE Adverse Event Report: DEXCOM DEXCOM G6 CONTINUOUS GLUCOSE MONITOR

Model Number G8

Device Problems Entrapment of Device (1212); Malposition of Device (2616)

Patient Problems Extravasation (1842); Tissue Damage (2104); Blood Loss (2597)

Event Date 08/10/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, when changing the dexcom g6 sensor prior to the 10 day replacement period, the transmitter was stuck in the wrong orientation in the sensor for the continuous blood glucose monitoring machine.The sensor was already inserted into the skin and kitchen objects such as forks and knives were used to dislodge the transmitter from the device that was inserted in the skin but the transmitter would not release.The device had to ripped out of the skin and destroyed to release the transmitter.The big end of the transmitter was inserted but this small end was not inserted due to the wrong insertion orientation and the sensor had to be destroyed.Blood was leaking from the insertion site after removal.I contacted the distributor dexcom on same day but it is unlikely that the complaint was filled, and a replacement sensor was offered.Product sensor was discarded.

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 7780298
• MDR Text Key: 117257775
• Report Number: MW5079109
• 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: Patient
• Type of Report: Initial
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: G8
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 102