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

Model Number 9438-06

Device Problem Wireless Communication Problem (3283)

Patient Problem Loss of consciousness (2418)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient experienced a hypoglycemic event and a loss of consciousness.Hospice nurse found patient unresponsive.Patient reported that her blood glucose (bg) value was 31 mg/dl.Patient's continuous glucose monitor (cgm) was unavailable due to signal loss.Hospice nurse treated patient with an iv of dextrose.Patient's bg was then at 156 mg/dl.Emergency medical services (ems) arrived and monitored patient, but did not administer any treatment.Patient was not transported to hospital.Patient alleges that they did not receive an alert for the low due to a loss of connection between transmitter, receiver, and smart device.At the time of contact, patient was fine.No additional patient or event information was provided.Data was provided for evaluation.The reported loss of connection was confirmed via data.A root cause could not be determined.

• 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: 6509121
• MDR Text Key: 73326935
• Report Number: 3004753838-2017-26400
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000221
• UDI-Public: (01)10386270000221(241)STT-GF-001(10)6001161(15)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: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9438-06
• Device Catalogue Number: STT-GF-001
• Device Lot Number: 6001161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 60