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

Model Number MT20649-PNK

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

Patient Problems Fatigue (1849); Hypoglycemia (1912); Nausea (1970); Seizures (2063)

Event Date 01/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016, to report a possible hypoglycemic event and possible seizure that occurred on (b)(6) 2016.Patient was shopping went she felt weak and nauseous.Patient did not pass out.The store manager called the paramedics.Patient was taken to the emergency room (er) by ambulance.Patient was at the hospital from 4:00 pm to 8:00 pm and reported that she had several tests done, to include a mri and a cardio test.Patient was given a 20oz.(b)(6), and reported that the blood glucose (bg) meter reading was 117mg/dl.At the time of contact, the patient reported she had a follow up visit with her physician on (b)(6) 2016 for the reported event.Physician prescribed nph insulin, to take once daily in the morning in addition to her daily regimen.Additionally, patient reported that she was seen by a neurologist for the reported event.The neurologist ran tests and concluded that he thinks the patient had a seizure, rather than a hypoglycemic event.Patient was given a prescription for seizures.Patient does not recall the name of the seizure medication.It was further reported that the patient is on several medications.Patient declined to report medication list.At the time of contact, patient reported current condition as "fine".No additional event or patient information is available.The complaint states that the patient experienced a possible hypoglycemic event and a possible seizure on (b)(6) 2016.It should be noted that diabetes mellitus is a known cause of hypoglycemia and seizures.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego 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: 5398194
• MDR Text Key: 37085725
• Report Number: 3004753838-2016-00754
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000088
• UDI-Public: (01)00386270000088(241)MT20649-PNK(10)5106249(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: 01/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-PNK
• Device Catalogue Number: STK-GL-PNK
• Device Lot Number: 5106249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2013
• 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: 67 YR
• Patient Weight: 68