• 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 MT22495
Device Problem Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver ceased to function.No additional event or patient information is available.The device has been received for investigation.A follow-up will be submitted upon completion of device investigation.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The product was evaluated.An external visual inspection was performed and failed due to usb pin(s) from j3 are damaged.Pictures were taken.Receiver charge and boot testing were performed and failed due to usb pin(s) from j3 are damaged.An internal visual inspection was performed and passed.The log was not downloaded because usb connector damaged.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS 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 Key8170127
MDR Text Key130521695
Report Number3004753838-2018-157791
Device Sequence Number1
Product Code MDS
UDI-Device Identifier30386270000157
UDI-Public30386270000157
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 Other
Type of Report Initial,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMT22495
Device Catalogue NumberSTR-DR-BLU
Device Lot Number5231390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/18/2018
Initial Date FDA Received12/17/2018
Supplement Dates Manufacturer Received09/17/2019
Supplement Dates FDA Received10/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age5 YR
-
-