• 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 MDS

  • 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 MDS Back to Search Results
Model Number 9500-27
Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/12/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced a detached sensor wire on (b)(6) 2016. The sensor was inserted into the thigh on (b)(6) 2016. Patient's mother was unable to find the sensor wire upon removal of the sensor pod. Patient's mother took the patient to the urgent care at approximately 7:00pm on (b)(6) 2016. The patient was admitted and had an x-ray performed. The x-ray found that the sensor wire was lodged under the patient's skin. The patient was discharged at approximately 9:00pm. On (b)(6) 2016, the patient had a second x-ray performed and it confirmed that the sensor wire was stuck between the muscle tissue and skin. The doctor could not remove the sensor wire and referred the patient to a different doctor, who surgically removed the sensor wire on (b)(6) 2016. No additional event or patient information was provided. The sensor was inserted into the thigh. The dexcom g5 mobile continuous glucose monitoring system states: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites. If placed in other areas, the dexcom g5 mobile system may not function properly. Additionally, the transmitter was removed prior to removal of the sensor pod. The dexcom g5 mobile continuous glucose monitoring system states: do not remove the transmitter before removing the sensor pod from your body.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Event Description
A sensor (serial number (b)(4)/lot number 5205269) was returned for evaluation a visual inspection was performed and the sensor wire was missing from the sensor pod and housing puck. Due to the missing sensor wire, the sensor wire is considered detached. The reported event of a detached sensor wire was confirmed. A root cause could not be determined. However, it is unknown if the returned product is the complaint device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
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 Key5740659
MDR Text Key47900648
Report Number3004753838-2016-03521
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,Followup,Followup
Report Date 05/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2016
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 Received09/28/2016
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: 06/22/2016 Patient Sequence Number: 1
-
-