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

Model Number 9438-05

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the transmitter allegedly stopped working prior to the end of warranty.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of the transmitter allegedly stopped working prior to the end of warranty could not be determined.A 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 dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7525954
• MDR Text Key: 108743522
• Report Number: 3004753838-2018-053790
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000125
• UDI-Public: 00386270000125
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

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: 9438-05
• Device Catalogue Number: STT-GL-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 19 YR