MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number MT20649-3

Device Problem Wireless Communication Problem (3283)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The age field entry does not represent the date of birth of the patient and should be read as ¿no information.¿.

Event Description

It was reported that signal loss over one hour occurred.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, additional information is available.

Event Description

It was reported that signal loss over one hour occurred.The product was evaluated.An external visual inspection was performed and passed.Charge and boot was performed and passed.Paring tests were performed and passed.Functional tests were performed and passed.A review of the receiver logs was performed and signal loss was not found within the investigation window.The allegation was not confirmed.The probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 10887053
• MDR Text Key: 217983172
• Report Number: 3004753838-2020-131424
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-3
• Device Catalogue Number: STK-JP-019
• Device Lot Number: 5253169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 118 YR