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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Renal Failure (2041)

Event Date 04/12/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of death.

Event Description

Patient's wife contacted dexcom on 04/13/2016 to report that the patient passed away on (b)(6) 2016.Patient's wife called the emergency medical technicians (emts), as the patient was not doing well.He had recently changed his blood pressure medication.The patient was transported to the hospital, but they were not equipped to care for the patient.He was then transported to a different hospital.Patient's wife stated that the patient had several procedures performed, including a tracheotomy.He also had a procedure performed involving his neck and a saline solution to bring swelling in his brain down.Additionally, the patient experienced failing kidneys.Patient's wife stated that the patient passed away due to a brain hemorrhage while at the second hospital.At the time of the patient's death, he was wearing the continuous glucose monitor.However, there was no alleged device malfunction.A certificate of death was not provided.No further event or patient information is available.

Manufacturer Narrative

(b)(4).

Event Description

The receiver (lot number 5086279) being used at the time of death was returned for evaluation.The device was visually inspected and no defect was found.Functional testing was performed and there was no failure detected.The receiver log was reviewed and no errors were observed.There was no alleged malfunction to the device.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5652193
• MDR Text Key: 45090507
• Report Number: 3004753838-2016-02939
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NI(241)NI(10)NI(17)NI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 60 YR