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

Model Number MT20649-2

Device Problem Defective Alarm (1014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, an intermittent audio output occurred.No additional event or patient information is available.No product or data was provided for evaluation.Confirmation of the complaint and a root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The product was evaluated.An external visual inspection was performed and passed.Charge and boot testing was performed and passed.The receiver log download passed.Receiver functional testing was performed and passed.The log was downloaded and reviewed finding no data.A comm tool audio test was performed and passed.A "try-it" test was performed and passed.The receiver case was opened, and an internal visual inspection was performed and passed.A speaker measurement test was performed and passed.The allegation was not confirmed.The probable cause could not be determined.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 CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence drive; san diego, ca, CA 92121 ; 8582000200
• MDR Report Key: 8173861
• MDR Text Key: 131066426
• Report Number: 3004753838-2018-156283
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-2
• Device Catalogue Number: STK-GL-117
• Device Lot Number: 5235208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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