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

Catalog Number UNKNOWN

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

Patient Problems Fall (1848); Hyperglycemia (1905); Swelling (2091); Diabetic Ketoacidosis (2364)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that an adverse event that occurred on (b)(6) 2016.The patient stated that she was experiencing frequent urination, fell and hit her head.An ambulance took her to the hospital and her blood glucose (bg) was over 700mg/dl.Patient had some brain swelling from hitting her head and diabetic ketoacidosis.The patient was in the intensive care unit (icu) and was released from the hospital after 4 days.There was no alleged device malfunction.At the time of contact, the patient was okay but fatigued.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING 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: 5652915
• MDR Text Key: 45118597
• Report Number: 3004753838-2016-02965
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NI(241)NI(10)NI(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: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 58 YR
• Patient Weight: 53