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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS Back to Search Results
Model Number MT22495
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 01/11/2016
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's daughter contacted dexcom on (b)(6) 2016, to report a patient death that occurred on (b)(6) 2016. Patient's daughter reported that the cause of death was cardiac arrest. Patient's daughter declined to give further information. It is unknown if the patient was wearing dexcom continuous glucose monitor (cgm). No additional event or patient information is available. There was no alleged device malfunction. It was stated that patient expired from cardiac arrest. It should be noted that diabetes mellitus is a known cause of death. However, a conclusive root cause for the reported event cannot be confirmed without the certificate of death.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
Type of DeviceMDS
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego 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 Key5428439
MDR Text Key37933579
Report Number3004753838-2016-01041
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 01/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTK-DR-001
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 Received01/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/10/2016 Patient Sequence Number: 1
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