• 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

  • 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 Back to Search Results
Model Number 9500-27
Device Problems Use of Device Problem (1670); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, there was a reported missing sensor wire. The sensor was inserted into the arm on (b)(6) 2018. The device has been received for investigation. A follow-up will be submitted upon completion of device investigation. The transmitter was removed prior to the removal of the sensor pod. Confirmation of the problem and probable cause could not be determined. Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen). No additional event or patient information is available. Labeling indicates: do not remove the transmitter while the sensor pod is still attached to the body. Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen). No additional event or patient information is available.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A sensor was returned for evaluation. A visual inspection was performed and found that the sensor wire is missing from the sensor pod and seal carrier. The reported event of a missing or detached wire was confirmed. A probable cause could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key7323600
MDR Text Key102105710
Report Number3004753838-2018-023803
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public00386270000019
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
Report Date 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/19/2018
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5229717
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-