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

Model Number 9438-06

Device Problem Wireless Communication Problem (3283)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced a loss of connection and an adverse event on (b)(6) 2016.Patient had a hypoglycemic event that lead to a seizure.Patient's mother called 911 at approximately 4:45 am.An ambulance and emergency medical technicians (emts) arrived within minutes and transported patient and patient's mother to the emergency room, where the patient was given an iv with fluids, zofran, and an anti-seizure medication.Patient was not as admitted to the hospital and stayed in the emergency room for observation until after 2:00 pm.At the time of contact, it was reported that the patient was exhausted and sore.No additional patient or event information is available.The complaint device was not returned for evaluation.However, the data log was provided by the patient.The data was reviewed on 05/20/2016 and did not confirm the reported loss of connection.A root cause could not be determined.

• 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: 5681307
• MDR Text Key: 45959398
• Report Number: 3004753838-2016-03189
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000224
• UDI-Public: (01)00386270000224(241)9438-06(10)5208667(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: 05/01/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9438-06
• Device Catalogue Number: STT-GF-001
• Device Lot Number: 5208667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2016
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2016
• 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: 8 YR
• Patient Weight: 32