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

Model Number MT22495-PNK

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

Patient Problems Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of diabetic ketoacidosis, hyperglycemia and its associated effects.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report an adverse event that occurred on (b)(6) 2016.The patient stated that while at the hospital visiting her granddaughter, she was hyperglycemic and was vomiting.Patient's insulin pump was not giving her the insulin she needed.However, her continuous glucose monitor (cgm) was alerting her that she was high.Patient's daughter drove the patient home and once there, the patient's husband drove the patient to the hospital.Patient experienced being comatose, had ketoacidosis and also had oral thrush due to her high blood glucose.The patient was put on an insulin drip and intravenous drip and kept for observation for 3 days.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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: 5602257
• MDR Text Key: 43433752
• Report Number: 3004753838-2016-02583
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000163
• UDI-Public: (01)00386270000163(241)MT22495-PNK(10)5210023(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: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-PNK
• Device Catalogue Number: STR-DR-PNK
• Device Lot Number: 5210023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2015
• 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): Hospitalization; Other
• Patient Age: 48 YR
• Patient Weight: 68