MAUDE Adverse Event Report: DEXCOM, INC.; CONTINUOUS GLUCOSE MONITOR

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

Patient Problems Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 03/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of diabetic ketoacidosis.

Event Description

Dexcom was made aware on (b)(6) 207 that on (b)(6) 2017, patient experienced symptoms including throwing up blood, dehydration, and a blood glucose (bg) of 571 mg/dl.Patient drove herself to hospital.Patient was treated for dehydration and released same day, although still throwing up blood.On (b)(6) 2017, patient was still throwing up blood.Patient called 911.Patient was transported to hospital by ambulance.Patient was admitted for diabetic ketoacidosis.Patient was released from the hospital on (b)(6) 2017.At the time of event, patient was not using the dexcom system.At the time of contact, patient is not throwing up.No additional event or patient information is available.No product or data was provided for evaluation.The customer complaint could not be confirmed.A root cause could not be determined.

• Brand Name: NA
• 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: 6513528
• MDR Text Key: 73419723
• Report Number: 3004753838-2017-26362
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• 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
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROTONIX
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 32 YR