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 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

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

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Please disregard reporting of additional medical device information from follow-up #: 001 of mfr 3004753838-2018-146573 as this supplemental information was reported in error.

Event Description

Subsequent to the first supplemental mdr, it was determined that a report was submitted in error.Upon further review, it was determined that medical device information was not available to dexcom as dexcom technical support was unable to make contact with the patient.

• 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: 8108873
• MDR Text Key: 128764564
• Report Number: 3004753838-2018-146573
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup
• Report Date: 01/24/2020

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: 9438-05
• Device Catalogue Number: STT-GL-004
• Device Lot Number: 5242769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 09/17/2019; 01/23/2020
• Supplement Dates FDA Received: 01/16/2020; 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2018
• 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
• Patient Age: 44 YR