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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9445-02
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2018
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 confirmed via data. The probable cause was determined to be a low transmitter battery that led to a transmitter failure. No additional patient or event information is available.
 
Manufacturer Narrative
(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 confirmed the reported event of a failed transmitter error. The probable cause was determined to be a low transmitter battery. No additional patient or event information is available.
 
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Brand NameDEXCOM G6 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 Key8030768
MDR Text Key125941008
Report Number3004753838-2018-132976
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9445-02
Device Catalogue NumberSTT-OR-001
Device Lot Number5240500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2018
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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