• 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 9438-06
Device Problem No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/16/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that transmitter failed error occurred.Data was evaluated and the allegation was confirmed.The probable cause was determined to be a low transmitter battery.No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that transmitter failed error occurred.The product was evaluated.An external visual inspection was performed and passed.Voltage test was performed and failed due to 0v.A review of the share logs was performed and transmitter failed error was found within the investigation window.The allegation was confirmed.The probable cause was determined to be a low transmitter battery.No injury or medical intervention was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key9772541
MDR Text Key181532389
Report Number3004753838-2020-020186
Device Sequence Number1
Product Code PQF
UDI-Device Identifier20386270000228
UDI-Public20386270000228
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 04/13/2020
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 Number9438-06
Device Catalogue NumberSTT-RF-001
Device Lot Number7255797
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/16/2020
Initial Date FDA Received02/29/2020
Supplement Dates Manufacturer Received03/30/2020
Supplement Dates FDA Received04/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2019
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 Age31 YR
Patient Weight84
-
-