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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 MT22495
Device Problem Wireless Communication Problem (3283)
Patient Problems Headache (1880); Nausea (1970)
Event Date 10/20/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known contributor to nausea and headaches.
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced a loss of connection between the transmitter and receiver and an adverse event. The patient reported that they had nausea and a headache during a period of loss of connection and scheduled a doctor's appointment. Patient went to their endocrinologist's office and was given basal insulin as well as having had their insulin pump settings adjusted. Patient kept in contact with their doctor overnight. At the time of contact, the patient was fine. Additional event or patient information is not available. No product or data was provided for evaluation. The reported event of loss of connection was not confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and "call tech support" error was observed on the screen. The data log could not be retrieved and functional testing could not be performed because of the "call tech support" error. The customer complaint could not be confirmed because it could not be determined if any error occurred on the date of event. The root 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 drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key6115302
MDR Text Key60411795
Report Number3004753838-2016-52746
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 10/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTK-DR-001
Device Lot Number5202879
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/18/2016 Patient Sequence Number: 1
Treatment
INSULIN PUMP
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