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

Catalog Number UNKNOWN

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

Patient Problems Death (1802); Pneumonia (2011); Septic Shock (2068); Multiple Organ Failure (3261); Cancer (3262)

Event Date 12/20/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Patient's brother contacted dexcom on (b)(6) 2016, to report a patient death that occurred on (b)(6) 2015.Patient's brother reported that the patient went to the hospital on (b)(6) 2015 because he was feeling sick.It was determined that the patient had pneumonia.On monday, (b)(6) 2015, the patient was transferred to another hospital.Later on, while patient was at the hospital patient learned that his leukemia had returned.Patient passed away on (b)(6) 2015.It is unknown if the patient was wearing dexcom continuous glucose monitor (cgm) at the time of the reported event.Cause of death was reported to be from severe refractory shock, multi-organ failure, and cmml iblast crisis.Medications and treatments are unknown.No additional event or patient information is available.There was no alleged device malfunction.A certificate of death was provided, confirming patient expired as a result of severe refractory shock, multi-organ failure, and cmml iblast crisis.It should be noted that diabetes mellitus is a known cause of death related to complications of the disease.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego 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: 5443766
• MDR Text Key: 38432006
• Report Number: 3004753838-2016-01085
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NI(241)NI(10)NI(17)NI
• Combination Product (y/n): N
• 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: 01/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• 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: 01/24/2016
• 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; Hospitalization; Other
• Patient Age: 43 YR
• Patient Weight: 82