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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9438-06
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that the display device showed a transmitter failed error on (b)(6) 2018. Data was returned and evaluated. The reported event of a transmitter failed error was not confirmed via data. A probable cause could not be determined. No additional patient or event information is available.
 
Manufacturer Narrative
Com-(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected, and no defect was found. Voltage testing was performed, and the test failed. A review of the downloaded data log did not confirm the reported event of failed transmitter error. A probable cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE 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 Key8145073
MDR Text Key129773574
Report Number3004753838-2018-153639
Device Sequence Number1
Product Code MDS
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 03/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9438-06
Device Catalogue NumberSTT-MC-001
Device Lot Number7242717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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