MAUDE Adverse Event Report: DEXCOM, INC.

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

Patient Problems Death (1802); Swelling (2091); Cancer (3262)

Event Date 03/31/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on 05/16/2017, that the patient passed away on (b)(6) 2017.On (b)(6) 2017, the patient went to the hospital due to leg swelling.A computed tomography (ct) scan was performed and metastatic cancer was found in the patient's abdomen.The patient was diagnosed with cancer the same day.The patient spent approximately three weeks in the hospital.The patient was transferred to hospice care on (b)(6) 2017.The patient passed away on (b)(6) 2017.It was reported that the patient's cause of death was metastatic cancer.It was indicated that the patient was on medications for blood pressure and gout.It was reported that the patient was only using the dexcom system for four days until he passed away.There was no alleged device malfunction.Patient's wife contacted dexcom to cancel supplies.A certificate of death was not provided.No additional event or patient information is available.

• Brand Name: NA
• Type of Device: NA
• 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: 6611060
• MDR Text Key: 76654902
• Report Number: 3004753838-2017-47741
• Device Sequence Number: 1
• Product Code: MDS
• 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
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2017
• 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
• Treatment: BLOOD PRESSURE MEDICATION; GOUT MEDICATION; INSULIN
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 100