MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number MT24078

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the receiver was overheating.Product was received but its pending evaluation.A follow up report will be submitted upon completion.No injury or medical intervention was reported.

Event Description

The product was evaluated.An external visual inspection was performed and passed.Receiver charge and boot tests were performed and failed due to the receiver not turning on even with another good known battery.Functional tests were not performed due to the receiver not turning on.An internal visual inspection was performed and passed.The receiver log was not downloaded for review due to the receiver not turning on.The allegation was was undetermined.The probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 15753039
• MDR Text Key: 307078609
• Report Number: 3004753838-2022-207913
• Device Sequence Number: 1
• Product Code: QDK
• UDI-Device Identifier: 00386270000583
• UDI-Public: 00386270000583
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K182041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT24078
• Device Catalogue Number: STR-OR-001
• Device Lot Number: 5266230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 37 KG