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

Model Number MT20649-1

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the receiver had no audio output occurred.No product or data was provided for evaluation.Confirmation of the allegation and a root cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

The product was evaluated.The device was visually inspected and passed.The receiver charged and rebooted.The receiver download retrieve and attach passed.The log was downloaded and reviewed finding no errors related to the complaint.The receiver functional test failed audio.The receiver "try-it" sound test was performed, and failed audio.The receiver case was opened for an internal inspection and it passed.The receiver speaker resistance measure was performed and failed.The allegation was confirmed.The probable cause was defective speaker.No injury or medical intervention was reported.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8948026
• MDR Text Key: 156094048
• Report Number: 3004753838-2019-62924
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-1
• Device Catalogue Number: STK-GL-008
• Device Lot Number: 5223121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2016
• 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