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

Catalog Number SW12585

Device Problem No Audible Alarm (1019)

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

Event Date 10/22/2021

Event Type  malfunction  

Event Description

It was reported no audio output occurred.Data was evaluated and the allegation was confirmed.The device functioned within specifications and patient settings.The probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).B5: describe event or problem - correction.H2: if follow-up, what type - correction.H6: adverse event problem - correction.

Event Description

Data was evaluated and the allegation was confirmed.The probable cause of the missed alert is either a race condition on app startup which intermittently resets the user¿s customized alert settings to default thresholds and/or an internal database write issue clearing some or all alerts upon app termination.

• Brand Name: DEXCOM ONE 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: 12758647
• MDR Text Key: 281429839
• Report Number: 3004753838-2021-255878
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: LH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: SW12585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2022
• 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: 38 YR
• Patient Sex: Female