MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and loss of consciousness.

Event Description

Dexcom was made aware on 03/30/2017 that on (b)(6) 2017, that the patient experienced a hypoglycemic event.Patient was at home when he passed out.A neighbor came to check on patient.Patient did not answer the door.Patient's neighbored entered the home and found patient on floor.The neighbor called an ambulance.An emergency medical technician (emt) treated patient with glucagon.Patient was transported to emergency room (er).Patient stayed overnight at the hospital for observation, and left on (b)(6) 2017.At the time of event, patient was not using the dexcom system.At the time of contact, patient is doing well.No additional patient or event information was provided.No product or data was provided for investigation.The reported event could not be confirmed.The root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM 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: 6527281
• MDR Text Key: 73867605
• Report Number: 3004753838-2017-26373
• 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: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• 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: 03/30/2017
• 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): Hospitalization; Other
• Patient Age: 70 YR