MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

Catalog Number STR-OR-001

Device Problem No Audible Alarm (1019)

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

Event Date 12/18/2022

Event Type  Injury  

Event Description

It was reported that no audio output occurred.On (b)(6) 2022, the patient experienced no audio output an unspecified number of days after the sensor had been inserted into an undisclosed location.The patient experienced hypoglycemia and loss of consciousness.The patient's daughter found her unconscious and called paramedics who administered iv glucose and she recovered after treatment.The patient was not transported to the hospital.At the time of the report, the patient was feeling well.No product or data was provided for evaluation.The allegation and a probable cause could not be determined.No additional patient or event information was available.

Manufacturer Narrative

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

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 16190486
• MDR Text Key: 307557445
• Report Number: 3004753838-2023-013867
• Device Sequence Number: 1
• Product Code: QDK
• UDI-Device Identifier: 00386270000583
• UDI-Public: 00386270000583
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: DEN170088
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/20/2022
• Device Catalogue Number: STR-OR-001
• Device Lot Number: P11845990
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• 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; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Female