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

Model Number 9438-05

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a transmitter failed error occured.No additional event or patient information is available.No product or data was provided for evaluation.The complaint confirmation of the reported transmitter failed error could not be determined.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The product was evaluated.The device was visually inspected and passed.Voltage testing was performed and failed due to no voltage.No log data available for review.Confirmation of the allegation and root cause could not be determined.

• 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: ying chen ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8204898
• MDR Text Key: 131723606
• Report Number: 3004753838-2018-163558
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9438-05
• Device Catalogue Number: STT-GL-004
• Device Lot Number: 5233559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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