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

Catalog Number SW11677

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a connection issue occurred.It was indicated that the operating system for the smart device was not a supported system, which is off-label usage of the device.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 connection issue is reportable based on the finding of signal loss greater than an hour.No injury or medical intervention was reported.

• Brand Name: DEXCOM G6 GLUCOSE PROGRAM 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: 12356631
• MDR Text Key: 267885520
• Report Number: 3004753838-2021-145368
• Device Sequence Number: 1
• Product Code: QDK
• UDI-Device Identifier: 00386270000804
• UDI-Public: 00386270000804
• Combination Product (y/n): N
• 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
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: SW11677
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR