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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
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Pneumonia (2011); Staphylococcus Aureus (2058); Seizures (2063); Diabetic Ketoacidosis (2364)
Event Date 12/03/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hyperglycemia, diabetic ketoacidosis and their associated effects.
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report that they experienced an adverse event on (b)(6) 2015. The patient was not wearing the continuous glucose monitor (cgm) at the time of the event, as the transmitter needed to be replaced, and the patient had not yet gotten around to doing so. Due to not having the cgm, the patient was manually monitoring his blood glucose (bg) and forgot to take insulin. That night, (b)(6) 2015, the patient's bg was at 500mg/dl and the patient started having seizures. The patient's son found him on the ground seizing and had to call an ambulance from the neighbor's phone. The patient's wife got home right when the police arrived. The paramedics came and the patient could not recall what happened after they arrived. The patient ended up having double pneumonia in his lungs due to intubation in the hospital and developed a staph infection. Patient also experienced diabetic ketoacidosis. The patient was in the hospital for 19 days. The patient was discharged on (b)(6) 2015. At the time of contact, the patient was in good condition. 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 Key5602879
MDR Text Key43440291
Report Number3004753838-2016-02519
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 03/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
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 Received03/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/23/2016 Patient Sequence Number: 1
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