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

Model Number 9438-01

Device Problem Wireless Communication Problem (3283)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and loss of consciousness.

Event Description

Dexcom was made aware on 07/09/2018, that on (b)(6) 2018, a loss of connection and hypoglycemic event were reported.The patient stated they were on vacation and the receiver had a loss of signal in which she had a hypoglycemic event.She indicated that she was hypo unaware and went unconscious for 3 hours.When she woke up, she ate some glucose tablets and carbs.At the time of contact, the patient was doing good.No additional patient or event information is available.No data or product was provided for evaluation.The complaint confirmation was unable to be determined.A root cause was not 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: 7732867
• MDR Text Key: 115596434
• Report Number: 3004753838-2018-84090
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9438-01
• Device Catalogue Number: STT-GL-004
• Device Lot Number: 5233484
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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): Other
• Patient Age: 47 YR
• Patient Weight: 98