MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 PROFESSIONAL SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 9500-80

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2023

Event Type  malfunction  

Event Description

It was reported that broken sensor wire occurred.The sensor was inserted into the abdomen on (b)(6) 2023.No product was provided for evaluation.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, a correction is required.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, additional information is available.

Manufacturer Narrative

(b)(4).

• Brand Name: DEXCOM G6 PROFESSIONAL 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: 18185629
• MDR Text Key: 328756973
• Report Number: 3004753838-2023-243224
• Device Sequence Number: 1
• Product Code: QII
• UDI-Device Identifier: 00386270001092
• UDI-Public: 00386270001092
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2024
• Device Model Number: 9500-80
• Device Catalogue Number: STP-PR-001
• Device Lot Number: 5322150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: Not provided; 11/22/2023
• Supplement Dates FDA Received: 11/21/2023; 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 10 KG