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

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

Patient Problems Hyperglycemia (1905); Renal Failure (2041); Sepsis (2067); Diabetic Ketoacidosis (2364)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on 09/15/2016, that (b)(6) 2016, the patient experienced an adverse event.The patient's wife woke up and found the patient was unresponsive and having respiratory problems.The patient's wife then called 911.The paramedics arrived and rushed the patient to the emergency room (er).The patient had a blood glucose level of 1040mg/dl.The patient was admitted the hospital and was diagnosed with diabetic ketoacidosis, sepsis and renal failure.The patient was given a slow-acting constant insulin drip and iv fluids.The patient was kept overnight and was discharged on (b)(6) 2016, after recovering.At the time of contact, the patient was at home recovering.There was no alleged device malfunction.Additional event or patient information is not available.No product or data was returned for evaluation.The reported event could not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM 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: 6015531
• MDR Text Key: 56912787
• Report Number: 3004753838-2016-80501
• 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: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 45 YR