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

Model Number 9500-44

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fainting (1847); Hypoglycemia (1912)

Event Date 03/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, that the patient's sensor fell off while he slept during the night and patient experienced a hypoglycemic event.Patient's symptom also was described as fainting.The sensor was inserted at the abdomen on (b)(6) 2017.The patient's dogs realized the hyperglycemic event and began to bark.Patient's wife was awakened by the barking dogs.Patient's wife treated patient with glucagon and called for an ambulance.The ambulance and staff arrived and administered glucose to the patient.Patient was not transported to hospital.Patient did not contact an emergency physician.No glucose values were provided.At the time of contact, patient is feeling 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.The patient did not clean the area before applying the sensor.Labeling indicates: clean your sensor placement site with an alcohol wipe to prevent infections.If your insertion site is not clean and completely dry, you run the risk of infection or the sensor pod not sticking and falling off.

• 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: 6527296
• MDR Text Key: 73868419
• Report Number: 3004753838-2017-27693
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2017

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
• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-001
• Device Lot Number: 5220418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2016
• 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: 52 YR
• Patient Weight: 98