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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 MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-35
Device Problem Detachment Of Device Component (1104)
Patient Problems Skin Inflammation (2443); Foreign Body In Patient (2687)
Event Date 02/07/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Distributor contacted dexcom on behalf of the patient on (b)(6) 2016, to report a detached sensor wire that occurred on (b)(6) 2016. The sensor insertion was at the buttocks on (b)(6) 2016. Upon removal of the sensor, they could not see the sensor wire. The distributor reported that the patient experienced inflammation around the insertion site on (b)(6) 2016. On (b)(6) 2016, the patient's mother took the patient to the hospital where an x-ray was taken. The x-ray confirmed that the sensor wire remained in the patient's skin. On (b)(6) 2016, the patient was given full anesthesia and the sensor wire was surgically removed. Additionally, during discussion with the distributor, patient's mother reported that she thinks that they may have done something wrong when they installed the sensor because they pushed down on the plunger while they pulled back. At the time of contact, the patient's mother reported the patient in "fine" condition. No additional event or patient information is available.
 
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Brand NameDEXCOM G4 PLATINUM 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 Key5492489
MDR Text Key40073654
Report Number3004753838-2016-25549
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeNO
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 02/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2016
Device Model Number9500-35
Device Catalogue NumberSTS-GL-005
Device Lot Number5203834
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 Received02/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2015
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: 03/10/2016 Patient Sequence Number: 1
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