MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Catalog Number UNKNOWN

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

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

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient's mother contacted dexcom on 05/02/2016 to report that the patient experienced an adverse event on (b)(6) 2016.Patient's mother stated that the patient was hospitalized due to diabetic ketoacidosis (dka).Patient's insulin pump had failed and the patient's blood sugar was greater than 620mg/dl.Patient was in the intensive care unit (icu) from 10:00 am to 9:00 pm and was given an iv and insulin.Patient was discharged from the hospital the following day.At the time of the event, the patient was not wearing the continuous glucose monitor (cgm) due to sensor shipping issues with the distributor.At the time of contact, it was reported that the patient was doing quite well.No additional event or patient information was provided.

• Brand Name: DEXCOM G5 MOBILE 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: 5684034
• MDR Text Key: 46061343
• Report Number: 3004753838-2016-03258
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• 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: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 13 YR