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

Model Number MT22495-BLU

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

Patient Problems Death (1802); Cancer (3262)

Event Date 01/18/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

Patient's wife contacted dexcom on (b)(6) 2016 to report that the patient passed away on (b)(6) 2016.The patient was diagnosed with pancreatic cancer and during their last two weeks was in very bad health.Patient was taken off medications two weeks prior to passing and was only using insulin.On (b)(6) 2016, patient was given morphine and died at home under hospice care.No hospital visit was needed.Patient was wearing the cgm device at the time of death.There was no alleged device malfunction.Cause of death was reported to be pancreatic cancer.A death certificate was not provided.No additional event or patient information is available.

Manufacturer Narrative

(b)(4).

Event Description

The receiver being used at the time of event was returned for evaluation.The device was visually inspected and no defect was found.Functional testing was performed and there was no failure detected.A review of the downloaded receiver did not observe any errors.There was no alleged malfunction to the device.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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: 5518788
• MDR Text Key: 40922559
• Report Number: 3004753838-2016-01888
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000170
• UDI-Public: (01)00386270000170(241)MT22495-BLU(10)5201410(17)NA
• 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: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-BLU
• Device Catalogue Number: STK-DR-BLU
• Device Lot Number: 5201410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• 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 Outcome(s): Death; Other
• Patient Age: 66 YR
• Patient Weight: 68