MAUDE Adverse Event Report: DEXCOM, INC. G6 GLUCOSE PROGRAM IOS APP MODULE; CONTINUOUS GLUCOSE MONITOR

Model Number 9445-24

Device Problem Unintended Application Program Shut Down (4032)

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

Event Date 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an app crash alert occurred.Data was evaluated and the allegation was undetermined.The probable cause could not be determined.However, potential patient misuse occurred as the mobile device lost power.No injury or medical intervention was reported.

• Brand Name: G6 GLUCOSE PROGRAM IOS APP MODULE
• 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: 14362332
• MDR Text Key: 299890179
• Report Number: 3004753838-2022-076875
• Device Sequence Number: 1
• Product Code: QDK
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K203089
• 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: 05/11/2022

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 Model Number: 9445-24
• Device Catalogue Number: SW12741
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/11/2022
• 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: 19 YR
• Patient Sex: Female