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 03/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on 03/23/2017, that on (b)(6) 2017, the patient experienced a low blood glucose event.Patient reported that they had low blood glucose and passed out.The patient's children called the paramedics who administered the patient a glucose iv.The patient was not taken to the hospital.There was no alleged device malfunction.At the time of event, the patient was doing fine.No additional event or patient information is available.No product or data was returned for evaluation.The reported low event could not be confirmed.A root cause was not 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: 6509476
• MDR Text Key: 73326951
• Report Number: 3004753838-2017-26358
• 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: 03/23/2017

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: 03/23/2017
• Initial Date FDA Received: 04/20/2017
• 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
• Treatment: AMLODIPINE; ATORVASTATIN; INSULIN PUMP
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 82