• 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 G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR

  • 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 G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dehydration (1807); Diarrhea (1811); Vomiting (2144)
Event Date 01/26/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on 02/09/2017, that on (b)(6) 2017, an adverse event had occurred. The patient's father reported that the patient was severely dehydrated. The patient's father stated that on (b)(6) 2017 the patient was throwing up and had diarrhea. The patient's father took the patient to the emergency room (er) in the afternoon and immediately the patient was given 3 bags of fluids for being so sick. The patient stayed in er for 4 hours since the patient was high on ketones. The patient stayed home until wednesday (b)(6) 2017, when he went back to school. No product defects or failures were alleged. At time of contact the patient's condition was at home. No additional event or patient information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINOUS 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 Key6386372
MDR Text Key69322726
Report Number3004753838-2017-15881
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 02/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2017
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 Received02/09/2017
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

Patient Treatment Data
Date Received: 03/07/2017 Patient Sequence Number: 1
-
-