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 Hypoglycemia (1912); Seizures (2063)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that they experienced an adverse event on (b)(6) 2016. Patient stated that they went for a 3. 5 mile run, then had breakfast. Patient then went for a 2. 5 mile power walk. After the walk, the patient's continuous glucose monitor (cgm) alerted him that his glucose was trending low. The patient tried to ingest some food but could not act fast enough. The cgm was reading 13mg/dl and the patient started to seize. The emergency medical technicians (emt's) were called, although the patient was unsure by whom. The patient was brought to the emergency room (er). Patient stated that the hypoglycemic event occurred at work. There was no alleged device malfunction. At the time of contact, the patient was in normal condition. No additional event or patient information was provided.

• 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: 5784456
• MDR Text Key: 49231237
• Report Number: 3004753838-2016-38607
• 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: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN
• 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: 06/13/2016
• 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: Initial

Patient Treatment Data

Date Received: 07/11/2016 Patient Sequence Number: 1