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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 MDS

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-27
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/16/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The dexcom g5 mobile continuous glucose monitoring system user's guide states: on rare occasions, the sensor wire may break or detach from the sensor pod. If a sensor wire breaks under the skin with no portion of it visible, don't remove it. Contact your healthcare professional if you have redness, swelling, or pain at the insertion site.
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report a detached sensor wire that occurred on (b)(6) 2016. The sensor was inserted into the abdomen on (b)(6) 2016. Patient stated that the location of the sensor wire was the stomach. On (b)(6) 2016 patient began experiencing pain at the insertion site and on (b)(6) 2016 spoke to her doctor regarding the event, and it was suggested she go in for an x-ray. No additional event or patient information was provided.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Subsequent to the initial mdr, additional information was received. The patient went to the doctor for an x-ray on (b)(6) 2016. The results of the x-ray was received and confirmed that the retained was confirmed but could not be seen under the skin. No further patient or event information is available.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
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 Key5602255
MDR Text Key43434046
Report Number3004753838-2016-02603
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 03/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/22/2016 Patient Sequence Number: 1
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