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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-44
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/30/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The dexcom g4 continuous glucose monitoring system user's guide states: there is a remote chance that a sensor fragment could remain under your skin if the sensor breaks while you are wearing it. If you think a sensor has broken under your skin, contact your healthcare professional and call dexcom's technical support.
 
Event Description
Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, of a detached sensor wire that was retained in the patient's skin. The sensor was inserted at the abdomen on (b)(6) 2017. Patient's mother removed the sensor pod and the sensor wire could not be seen. Patient went to hospital and had an x-ray was performed which confirmed the sensor wire was in abdomen. Physician's recommendation was not to remove the wire fragment if there was no symptom of inflammation or infection. No further event or patient information is available. Product was not provided for investigation. However, photographs were provided which confirmed the alleged malfunction. The root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM 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 Key6527255
MDR Text Key73868450
Report Number3004753838-2017-01906
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 03/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/23/2017
Device Model Number9500-44
Device Catalogue NumberSTS-GF-001
Device Lot Number5220419
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 Received03/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2016
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: 04/27/2017 Patient Sequence Number: 1
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