MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS 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 Key: 6544442
• MDR Text Key: 74421636
• Report Number: 3004753838-2017-40263
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• 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 Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• 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 Sequence Number: 1
• Treatment: STEROIDS
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 83