MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Catalog Number UNKNOWN

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

Patient Problems Virus (2136); Diabetic Ketoacidosis (2364)

Event Date 12/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient's mother contacted dexcom on (b)(6) 2015 to report an adverse event that occurred on (b)(6) 2015.Patient's mother stated that on (b)(6) 2015 the patient was hospitalized for diabetic ketoacidosis after being sick with a virus.There was no alleged device malfunction.No additional event or patient information was provided.Diabetes mellitus is a known cause of diabetic ketoacidosis.

Manufacturer Narrative

(b)(4).

Event Description

It was reported in the initial mdr submitted on (b)(6) 2016 that the patient experienced an adverse event on (b)(6) 2016.Additional information was received.The updated information is as follws.The patient went to the hospital for diabetic ketoacidosis on (b)(6) 2015.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• 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: 5400255
• MDR Text Key: 37178528
• Report Number: 3004753838-2016-00821
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NI(241)NI10)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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2016
• 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: 01/29/2016
• 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): Hospitalization; Other
• Patient Age: 4 YR