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

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

Patient Problems Vomiting (2144); Weakness (2145)

Event Date 02/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, an adverse event had occurred.The patient's husband stated that he had contacted emergency medical team (emt), shortly after observing his wife vomiting, and getting weak.Later the patient was taken to hospital where she was treated for a hypoglycemic event and acidosis.No readings were taken at this time.The patient's stay in hospital was from (b)(6) 2017 6:30am until (b)(6) 2017 6:45pm.It was stated that the patient's blood glucose readings were ranging from 800mg/dl to 600mg/dl.The patient received insulin intravenously and the patient's husband was not sure of type of treatment was given for the acidosis.No product defects or failures were alleged.At time of contact the patient's condition was doing much better.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINOUS 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: 6438030
• MDR Text Key: 70969803
• Report Number: 3004753838-2017-23389
• 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: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• 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: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 83 YR