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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

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seizures (2063); Diabetic Ketoacidosis (2364)
Event Date 04/13/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf. Diabetes mellitus is a known cause of diabetic ketoacidosis.
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient experienced a diabetic ketoacidosis (dka) and had seizures. On (b)(6) 2017 around 2:30pm, the patient's mom called from work to check on the patient. The patient's sister went to check on the patient and found the patient in a dka and was having seizures. The patient's continuous glucose monitor (cgm) read 400 mg/dl and had alerted but the patient's blood glucose wasover 600 mg/dl. It was indicated that the patient had taken steroids and went into a dka and had seizures. The patient's sister called the paramedics and was taken to the emergency room and was treated with 10 units of insulin and intravenous (iv) therapy. The content of the iv is unknown. The patient was released from the hospital the same day. At the time of contact, the patient was doing well. There was no alleged device malfunction. No additional patient or event information was provided. Labeling indicates that the dexcom receiver only reports glucose information between 40-400 mg/dl.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
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 Key6544442
MDR Text Key74421636
Report Number3004753838-2017-40263
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 04/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received04/17/2017
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: 05/04/2017 Patient Sequence Number: 1
Treatment
STEROIDS
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