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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 MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number MT20649-BLU
Device Problem Defective Alarm (1014)
Patient Problems Stroke/CVA (1770); Hypoglycemia (1912)
Event Date 03/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report an adverse event and intermittent audi ouput that occurred on (b)(6) 2016. The patient experienced a hypoglycemic event and had a diabetic stroke. Patient gave himself a glucagon shot. Patient did not receive medical attention. No additional event or patient information was reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report an adverse event and intermittent audio output that occurred on (b)(6) 2016. Subsequent to the initial mdr, additional information was received from the patient regarding their diabetic stroke. The patient stated they had a low and that they only intermittently hear the alarm go off. Patient stated that they have had so many lows that they frequently go into diabetic comas. The patient has a bad pancreas and has too much scarring. No other patient or event information is available.
 
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Brand NameDEXCOM G4 PLATINUM 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 Key5566489
MDR Text Key42260010
Report Number3004753838-2016-37116
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
Remedial Action Notification
Type of Report Initial,Followup
Report Date 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-BLU
Device Catalogue NumberSTK-GL-BLU
Device Lot Number5166425
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 Received04/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
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: 04/10/2016 Patient Sequence Number: 1
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