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 Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.Diabetes mellitus is a known cause of hypoglycemia.

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient experienced a hypoglycemic event.The date of issue is an approximation.At approximately 3:30 pm, the patient passed out and was unconscious.The patient's wife arrived at home to find the patient unconscious and contacted the paramedics.Upon arrival the paramedics checked the patient's blood glucose (bg) and it read 18 mg/dl.The paramedics administered the patient with glucagon from a tube that was prescribed by their physician.The patient did not recall how long the event lasted but started to feel better and was not transported to the hospital.Additionally, the patient stated that he had multiple ambulances/paramedic assistance during the 4 months that he was waiting for his transmitter to arrive.At the time of contact, the patient was doing fine.There was no allegation of malfunction against the dexcom system.The patient was not using the dexcom system at the time of event.No additional event or patient information is available.

• 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: 6582660
• MDR Text Key: 75686329
• Report Number: 3004753838-2017-44718
• 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: 05/02/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR