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

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

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced a seizure due to low blood glucose. The patient's brother came home and found the patient incoherent, called the paramedics and gave the patient honey. By the time the paramedics arrived, the patient's blood glucose was at 76mg/dl. No medication was administered by the paramedics and the patient was not transported to the hospital. Patient's father reported that they were not alerted to the low event due to the transmitter serial number not being entered into the g5 mobile application or their receiver. There was no alleged device malfunction. At the time of contact, the patient was doing well. Additional event or patient information is not available. No product or data was provided for evaluation. The reported low event could not be confirmed. A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• 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: 6072577
• MDR Text Key: 58985572
• Report Number: 3004753838-2016-80779
• Device Sequence Number: 1
• Product Code: MDS
• 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

• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/02/2016 Patient Sequence Number: 1