• 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

  • 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 Back to Search Results
Model Number MT22719
Device Problem No Audible Alarm (1019)
Patient Problems Hyperglycemia (1905); Vomiting (2144); Loss of consciousness (2418)
Event Date 04/12/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on 04/14/2017 that on (b)(6) 2017, the patient experienced no audio alert, hyperglycemia, and a loss of consciousness. Patient's father reported patient was feeling ill with stomach ache all day on (b)(6) 2017. Patient had been vomiting and most likely had not eaten, or eaten very little. Patient's father reported that the continuous glucose monitor (cgm) at 12:00 pm cgm read 150 mg/dl; at 12:00 am the cgm read 200 mg/dl; at 4:00 am the cgm read 300 mg/dl. Patient's father found patient unconscious in the hallway between 3:30 am and 4:00 am on (b)(6) 2017. Patient's father transported patient to hospital where he was placed in intensive care. At hospital, patient was treated with 10 units of insulin. Patient's blood glucose (bg) was checked and it was at 780 mg/dl. At the time of contact, being released from the hospital. Patient's father alleges a lack of audio alarm led to the adverse event. Additionally, the patient's father tested the receiver's alerts and they worked. No further event or patient information is available. No product or data was provided for investigation. The reported event could not be confirmed. The root cause could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G5 MOBILE 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 Key6544502
MDR Text Key74424085
Report Number3004753838-2017-40260
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
Remedial Action Recall
Type of Report Initial
Report Date 04/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMT22719
Device Catalogue NumberSTR-GF-001
Device Lot Number5222027
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 Received04/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3004753838-02/29/16-001C

Patient Treatment Data
Date Received: 05/04/2017 Patient Sequence Number: 1
-
-