MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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

Patient Problems Death (1802); Renal Failure (2041)

Event Date 08/31/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on 10/05/2016, that on (b)(6) 2016, the patient passed away.Patient's wife reported that the patient was in hospice care for 6 days and was transported to the hospital via ambulance.Patient's wife stated that the cause of death was renal failure.Patient was not wearing the continuous glucose monitor at the time of the event.There was no alleged device malfunction.Additional event or patient information is not available.No product or data was returned for evaluation.A certificate of death was not provided.The reported event was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE 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: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 6067068
• MDR Text Key: 58764782
• Report Number: 3004753838-2016-80792
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 63 YR
• Patient Weight: 72