MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 9438-05

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Seizures (2063); Concussion (2192); Loss of consciousness (2418)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced an adverse event.Patient reported that they were shopping at the store and passed out and hit their head.Patient got a concussion, had a diabetic seizure and was foaming at the mouth.When the patient regained consciousness, the emergency medical technicians (emts) were already onsite and took the patient to the hospital.The patient was administered glucagon while at the emergency room and ate food.Patient indicated that the event was potentially due to having received the low transmitter battery warning.At the time of contact, the patient was doing well.Additional event or patient information is not available.No product or data was provided for evaluation.The reported event was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM 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: 6119208
• MDR Text Key: 60620770
• Report Number: 3004753838-2016-52727
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000125
• UDI-Public: (01)00386270000125(241)9438-05(10)5194154(17)NA
• 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: 10/26/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9438-05
• Device Catalogue Number: STT-GL-003
• Device Lot Number: 5194154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• 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
• Treatment: LEVOTHYROXINE; MULTIVITAMIN
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 66