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

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.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5602879
• MDR Text Key: 43440291
• Report Number: 3004753838-2016-02519
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NI(241)NI(10)NI(17)NI
• 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: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 87