MAUDE Adverse Event Report: DEXCOM, INC.; MDS

Catalog Number UNKNOWN

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

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

Event Date 06/12/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

Patient's daughter contacted dexcom on (b)(6) 2016 to report that the patient passed away on (b)(6) 2016.Patient passed away at a medical center due to renal failure.The patient was not wearing the continuous glucose monitoring device at the time of incident.There was no alleged device malfunction.No additional event or patient information was provided.A certificate of death was not provided.No product or data was returned for evaluation.The reported event could not be confirmed.A root cause could not be determined.

• Brand Name: NA
• 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: 5804196
• MDR Text Key: 49869200
• Report Number: 3004753838-2016-38704
• 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
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• 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: 06/20/2016
• 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; Other
• Patient Age: 81 YR
• Patient Weight: 59