• 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 9500-27
Device Problem Detachment Of Device Component (1104)
Patient Problems Pain (1994); Foreign Body In Patient (2687)
Event Date 11/18/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, sensor wires were found detached inside the patient's skin. The latest sensor was inserted at the abdomen on (b)(6) 2016. Patient's father reported that the patient was complaining that the sensor was bothering her. The patient continued to grimace and said it hurt. Patient's father removed the sensor an hour after insertion and prior to the sensor starting up. Patient's father did not visualize the sensor wire on the skin side of the sensor pod when he removed the sensor. Nor did he visualize the sensor wire sticking out of the patient's abdomen upon sensor removal. The following day on (b)(6) 2016, patient returned home from school and complained of pain at the sensor site. At the sensor site was a bump, approximately ¼" in diameter that hurt when pressure was applied. Patient's father brought the patient to the emergency room (er). An x-ray exam confirmed (2) two sensor wires under the skin. Patient's father believes that patient had a prior instance of retained sensor wire. Patient's father stated that he had noticed several times before where the sensor wire was not attached to the sensor pod upon removal, and assumed that these detached from the sensor pod after removal and had fallen on the floor. The wires were not removed by er staff. Patient's father was advised to contact a pediatric surgeon. At the time of contact, patient is doing well. No product or data were provided for evaluation. The reported detached sensor wire could not be confirmed. A 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 Key6168391
MDR Text Key62184004
Report Number3004753838-2016-52962
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)NI(17)NI
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 11/20/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot NumberASKU
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 Received11/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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