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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 9500-27
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/13/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf. 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
Dexcom was made aware on 03/22/2017, 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 reported seeing her primary care doctor who referred her to a specialist for an x-ray and a sonogram. The senor wire was discovered approximately two (2) inches from the navel. Surgery to remove the wire was pending. At the time of contact, patient is okay. No additional event or patient information is available. No product or data was provided for investigation. The reported issue could not be confirmed. The root cause could not be determined.
 
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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 Key6507913
MDR Text Key73326524
Report Number3004753838-2017-26352
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)5220181(17)171018
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 03/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/18/2017
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5220181
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 Received03/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/20/2017 Patient Sequence Number: 1
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