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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 02/14/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report bleeding that occurred on (b)(6) 2016. Patient inserted the sensor into the abdomen on (b)(6) 2016 and then took a nap for about an hour. Patient then woke up and saw blood everywhere. Patient reported that bleeding began when patient inserted the sensor and patient believes he may have bled up to an hour. Patient's son drove him to the hospital around 12pm. Patient was given gauze and a (b)(6) to stop the bleeding. Patient was at hospital for about 2 hours. At the time of contact, patient was fine. There was no alleged device malfunction. No additional event or patient information was reported.
 
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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 Key5494130
MDR Text Key40113528
Report Number3004753838-2016-01622
Device Sequence Number1
Product Code MDS
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 02/15/2016
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? No
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot NumberASKU
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 Received02/15/2016
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: 03/10/2016 Patient Sequence Number: 1
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