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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 Problems Pain (1994); Foreign Body In Patient (2687)
Event Date 07/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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's mother contacted dexcom on 07/02/2016, to report a detached sensor wire and adverse event that occurred on (b)(6) 2016. The sensor insertion was at the abdomen on the (b)(6) 2016. The patient's mother stated that the detached wire remained under the patient's skin and the patient was feeling pain. The patient's mother stated that she first called dexcom at approximately 7:45 pm (b)(6) 2016. Then the patient's mother called the patient's endocrinologist at approximately 9pm and the endocrinologist recommended the patient's mother take the patient to emergency room to have sensor wire removed. The patient's mother took the patient to the emergency room at approximately 10pm. At approximately 12 am the patient had sensor removed by the emergency room doctor. The patient was released from the emergency room at approximately 1 am (b)(6) 2016. No further event or patient information is available.
 
Manufacturer Narrative
(b)(4) describe event or problem - additional, serial number - additional, additional information/device evaluation, device evaluated by manufacturer - additional, event problem and evaluation codes - additional.
 
Event Description
The complaint device was returned for evaluation. A visual inspection was performed and the sensor wire was detached from the housing puck. The customer complaint was confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Subsequent to the first follow-up; a sensor (serial #(b)(4)/lot #5211749) was returned for evaluation. It cannot be verified if this is the device at fault. A visual inspection was performed and found that the wire is attached to the sensor and housing puck. The customer's complaint of a missing/detached sensor wire was not confirmed. A root cause could not be determined.
 
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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 Key5823987
MDR Text Key50509913
Report Number3004753838-2016-38794
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)5211749(17)170503
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,Followup,Followup
Report Date 07/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/03/2017
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5211749
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2016
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: 07/26/2016 Patient Sequence Number: 1
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