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

Model Number 9438-06

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

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 05/06/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient contacted dexcom on 05/09/2016 to report that they experienced diabetic ketoacidosis on (b)(6) 2016.Patient stated that they went to the hospital.The date of the visit is unknown.Patient was not wearing the continuous glucose monitor (cgm) at the time of event, as they did not have access to hardware and were waiting on insurance approval for sensor refill.There was no alleged device malfunction.No additional patient or event information is available.

• 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: 5699581
• MDR Text Key: 46561817
• Report Number: 3004753838-2016-60240
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000224
• UDI-Public: (01)00386270000224(241)9438-06(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: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9438-06
• Device Catalogue Number: STT-GF-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 63 YR