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

Model Number 9445-02

Device Problem Wireless Communication Problem (3283)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that signal loss over one hour occurred.A review of the share logs was performed and a loss of connection was found within the investigation window.However, the device operated within specification.The allegation was not confirmed.The probable cause could not be determined.No injury or medical intervention was reported.

Event Description

Correction of product information.

Manufacturer Narrative

(b)(4).D4: product information - correction.H2: correction.H4: manufacturing date - correction.

• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 11097873
• MDR Text Key: 225494196
• Report Number: 3004753838-2020-165359
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9445-02
• Device Catalogue Number: STT-GS-003
• Device Lot Number: 7275321
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR