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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 Problems Dyspnea (1816); Hypoglycemia (1912); Vomiting (2144)
Event Date 04/28/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.
 
Event Description
Dexcom was made aware on (b)(6) 2016 of an adverse event the patient experienced on (b)(6) 2016. Patient's wife was on the phone with technical support (ts) regarding calibration, as her husband was unable to give directions. During the call, the ts representative could hear the patient vomiting and gasping for air. Patient was also heard mumbling and was unable to talk. Patient's wife was advised to call 911 because the patient sounded like he was having an emergency. Patient later gave an update regarding the event, stating that he had dropped very low, quickly and before he could respond was incoherent. Patient's wife called an ambulance and when the paramedics came he was stable due to the juice he had. Patient did not require any medical attention from the paramedics. There was no alleged device malfunction. No additional event or patient 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 Key5684159
MDR Text Key46061434
Report Number3004753838-2016-03235
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 04/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2016
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
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 Received04/28/2016
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: 05/26/2016 Patient Sequence Number: 1
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