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); Pneumonia (2011); Renal Failure (2041)

Event Date 01/22/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

Patient's husband contacted dexcom on (b)(6) 2016 to report that the patient passed away.Patient's husband stated that on (b)(6) 2016 the patient was taken to the hospital via ambulance.Patient was transferred to another hospital at her husband's request, where the patient spent the next four days.At that time, the patient's kidneys were no longer functioning and her lungs developed pneumonia.Patient was taken off life-support and passed on (b)(6) 2016.A cause of death was not reported.A certificate of death was not provided.The patient was not using the continuous glucose monitoring device at the time of passing, as the painkillers she took for back pain affected the system.There was no alleged device malfunction.No additional event or patient information was provided.

• 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: 5590847
• MDR Text Key: 43095241
• Report Number: 3004753838-2016-02376
• 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: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• 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: 03/21/2016
• 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
• Treatment: SINAPRYL
• Patient Outcome(s): Death; Other
• Patient Age: 69 YR
• Patient Weight: 86