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

Catalog Number SW12740

Device Problem Unintended Application Program Shut Down (4032)

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

Event Date 03/03/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an app crash occurred.No data or product was provided for evaluation.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.

Event Description

It was reported that an unexpected cgm app shut-off occurred.Data was evaluated and the allegation was confirmed.The probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

• Brand Name: G6 GLUCOSE PROGRAM ANDROID 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: 19000590
• MDR Text Key: 338901729
• Report Number: 3004753838-2024-073289
• Device Sequence Number: 1
• Product Code: QDK
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: SW12740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2024
• 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: 60 YR
• Patient Sex: Male