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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 9500-45
Device Problem Component Missing (2306)
Patient Problems Pain (1994); Foreign Body In Patient (2687)
Event Date 11/06/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, upon removal of the sensor pod from the patient body, the sensor wire had detached. The sensor was inserted at the abdomen on (b)(6) 2016. Patient's father reported that the patient said the insertion was painful, and that the sensor didn't start the initialization process. After some minutes, blood was observed around the sensor patch. Patient's father took out the sensor and immediately noticed that it didn't have the sensor wire attached to the sensor pod. Patient's father informed his diabetologist who advised an x-ray exam. The x-ray exam confirmed that the sensor wire was left inside the patient's abdomen-left side. On (b)(6) 2016, a surgical procedure was performed that successfully removed the sensor wire pieces. Patient's father reported that the procedure was difficult and lasted three (3) hours. No additional event or patient information is available.
 
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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 Key6139572
MDR Text Key61289265
Report Number3004753838-2016-53436
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeIT
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 11/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-45
Device Catalogue NumberSTS-GF-004
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 Received11/11/2016
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: 12/01/2016 Patient Sequence Number: 1
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