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); Ulcer (2274); Blood Loss (2597)

Event Date 02/20/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

Patient's son-in-law contacted dexcom on (b)(6) 2016 to report that the patient passed away on (b)(6) 2016.On (b)(6) 2016 the patient had some kind of rupture from an ulcer and their blood sugar kept increasing, as a side effect.The patient's granddaughter called the ambulance and the patient was taken to the hospital.Patient's blood loss could not be stopped and the patient died from internal bleeding on (b)(6) 2016 while at the hospital.Patient was wearing the cgm system at the time of the event.There was no alleged device malfunction.A death certificate was not provided and the cause of death could not be confirmed.No additional event or patient information is available.

• Brand Name: NI
• 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: 5515278
• MDR Text Key: 40830024
• Report Number: 3004753838-2016-01786
• 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: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• 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: 02/22/2016
• 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: 86 YR
• Patient Weight: 68