• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 08/10/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hyperglycemia and diabetic ketoacidosis.
 
Event Description
Dexcom was made aware on (b)(6) 2016 that the patient experienced an adverse event on (b)(6) 2016. The patient's father took a fingerstick of the patient which read 250mg/dl and the patient was bent over with abdominal pain. An ambulance was called and the patient's parents were instructed not to give the patient any food or water. The patient's father was not aware of any medication that may have been given to the patient by the paramedics and followed the ambulance to the hospital. The doctors diagnosed the patient with diabetic ketoacidosis. The patient had a blood test performed and was administered an iv with glucose drip. Patient also had their sugar levels monitored. At 9:30pm the patient was admitted to the pediatric intensive care unit (icu) overnight and on (b)(6) 2016 was moved to the regular pediatric floor. Later that night, the patient was moved back to the pediatric icu and on (b)(6) 2016 the patient showed improvement and was moved back to the regular pediatric floor. The patient was released from the hospital on (b)(6) 2016. At the time of contact, the patient had improved and had been sent home. There was no alleged device malfunction. No additional event or patient information was provided. No product or data was returned for investigation. The reported event could not be confirmed. A root cause could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS 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 Key5938018
MDR Text Key54263223
Report Number3004753838-2016-80254
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 08/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2016
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 Received08/18/2016
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: 09/08/2016 Patient Sequence Number: 1
-
-