• 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 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 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Nausea (1970)
Event Date 11/27/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hyperglycemia.
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, an adverse event had occurred. The patient stated that she was working at a hospital on (b)(6) 2016 and his sensor started falling off. At 5:00 am in the hospital the patient was feeling nauseous and saw her continuous glucose monitor (cgm) value was at 395mg/dl. The patient then took readings on a blood glucose meter that read 476mg/dl. The patient injected herself with insulin (5 unit) after, she felt nausea and became sick. A co-worker brought the patient down to the emergency room (er). The er doctor medicate the patient with 15 unit's insulin via iv. The patient was not admitted, but did stay in the er for two hours before being released to go home. No product defects or failures were alleged. At time of contact, the patient was healthy. No additional event or patient information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G4 PLATINUM 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 Key6211908
MDR Text Key63470195
Report Number3004753838-2016-88457
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 12/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2016
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 Received12/01/2016
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

Patient Treatment Data
Date Received: 12/29/2016 Patient Sequence Number: 1
-
-