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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 Problem Foreign Body In Patient (2687)
Event Date 06/06/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016 to report a detached sensor wire that occurred on (b)(6) 2016. The sensor was inserted into the abdomen on (b)(6) 2016. Patient's mother reported that she was unable to locate the sensor wire upon removal of the sensor pod. Patient's mother called back and reported that on (b)(6) 2016, patient was seen by a physician's assistant and referred to a dermatologist. Patient's mother stated that on (b)(6) 2016 patient was taken to a dermatology group. Patient's mother stated that a nurse looked at patient's insertion site and stated that they could not do anything. Patient's mother then contacted the doctor's office and was referred to a surgeon. On (b)(6) 2016 patient was seen by a surgeon. Patient's mother reported that the patient was examined, and the doctor recommended to call dexcom to see if the area where the wire was can still be used as an insertion site. Patient's mother was advised by dexcom that patient can use the approved sites or contact patient's endocrinologist for alternate sites, and avoid the area in question if possible. Patient's mother stated that she will contact the surgeon about removing the wire. At the time of contact, patient was healthy. No additional patient or event information was provided.
 
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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 Key5756236
MDR Text Key48371013
Report Number3004753838-2016-03628
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)5208566(17)170125
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 06/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/25/2017
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5208566
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 Received06/06/2016
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: 06/28/2016 Patient Sequence Number: 1
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