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

Model Number 9445-20

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient was unable to identify device issue therefore a more specific code could not be selected.The concluded cause is not adequately described by any other term.

Event Description

It was reported that a g6 pro device that stopped working occurred.Data was evaluated and the allegation was confirmed as signal loss greater than an hour was confirmed.The probable cause was determined to be signal loss.The probable cause of the signal loss could not be determined.The reported event of a sensor that stopped working is reportable based on the finding of signal loss greater than an hour.No injury or medical intervention was reported.

• 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: 15961846
• MDR Text Key: 307765220
• Report Number: 3004753838-2022-231185
• Device Sequence Number: 1
• Product Code: QII
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2022

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: 06/02/2023
• Device Model Number: 9445-20
• Device Catalogue Number: STP-PR-001
• Device Lot Number: 5312068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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