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); Cancer (3262)

Event Date 01/21/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Patient's husband contacted dexcom on (b)(6) 2016, to report a patient death that occurred on (b)(6) 2016.It was reported that the patient was wearing dexcom continuous glucose monitor (cgm) at the time of the reported event.Death was not cgm related.Patient passed away due to cancer.No additional event or patient information is available.There was no alleged device malfunction.It was stated that patient expired as a result of cancer.It should be noted that diabetes mellitus is a known cause of death.However, a conclusive root cause for the reported event cannot be confirmed without the certificate of death.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, additional information regarding the patient's death was reported.The patient was under hospice care at home suffering from aggressive malignant melanoma.The cause of death was malignant melanoma.No other event or patient information is available.

• 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: 5467910
• MDR Text Key: 39285374
• Report Number: 3004753838-2016-01405
• 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: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• 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: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 58 YR
• Patient Weight: 68