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

Model Number 9500-27

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

Patient Problems Dehydration (1807); Hyperglycemia (1905); Nausea (1970); Vomiting (2144)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) diabetes mellitus is a known cause of hyperglycemia and its associated effects.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that they experienced an adverse event on (b)(6) 2016.The sensor was inserted into the abdomen on (b)(6) 2016.Patient states that when she woke up at 6:00 a.M.She had the question marks symbol displayed on her device.The patient did a finger stick and had a blood glucose (bg) value of 333mg/dl.She proceeded to take 10 units of novolog insulin and drank 2 liters of water throughout the course of the next 6 hours.Patient stated that she was very dehydrated and decided to drive herself to the emergency room (er) at approximately 12:00 p.M.And arrived at approximately 12:30 p.M.The patient was treated by an endocrinologist and was treated with an iv containing saline and zofran for vomiting.The patient was released the next day, (b)(6) 2016, around 5:00 p.M.No additional event or patient information was provided.No product or data was returned for evaluation.The reported event could not be confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• 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: 5876940
• MDR Text Key: 52130661
• Report Number: 3004753838-2016-80057
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5203092(17)160811
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/11/2016
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-041
• Device Lot Number: 5203092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2015
• Is the Device Single Use?: Yes
• 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: 62 YR
• Patient Weight: 49