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); Vomiting (2144)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient's mother contacted dexcom on 06/30/2016 to report that the patient experienced a hyperglycemic event on (b)(6) 2016.The patient's mother stated she was at the hospital when she contacted dexcom.Earlier in the day, at 11:13 am, the dexcom receiver and dexcom follow application were showing the patient at 182mg/dl.The patient's mother stopped receiving data on her follower application after that.The patient's mother mentioned that 3 hours later, the patient started vomiting and was taken to the hospital.The hospital staff took the patient's fingerstick reading which read over 700mg/dl.The patient's dexcom receiver was working the whole time, only the follow application did not display readings.At the time of contact, the patient was stable with blood glucose (bg) values of high 400's.No additional event information was provided as the patient was still at the hospital.No product or data was returned for evaluation.The customer complaint could not be confirmed.A root cause could not be determined.

• 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: 5835350
• MDR Text Key: 50805803
• Report Number: 3004753838-2016-38897
• 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: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• 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: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 15 YR
• Patient Weight: 59