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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 03/21/2016
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 that they experienced a detached sensor wire on (b)(6) 2016. The sensor was inserted into the abdomen on (b)(6) 2016. The patient stated that upon removal of the sensor pod, the sensor wire remained under the skin, on the left side of the abdomen. However, they were unable to see it. Patient experienced some discomfort at the site and when the abdomen was extended they could feel a gas-like bubble exerting pressure but this was not painful. On (b)(6) 2016 the patient had an x-ray performed at the hospital in order to locate the sensor wire. The technician was unable to locate/view the sensor wire on the x-ray. The patient was advised to seek a follow-up with their primary care manager and given a referral for a general surgeon. No additional event or patient information was provided.
 
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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 Key5596158
MDR Text Key43271448
Report Number3004753838-2016-02539
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
Report Date 03/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2016
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5208506
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 Received03/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/29/2015
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: 04/21/2016 Patient Sequence Number: 1
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