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

Catalog Number STR-OR-001

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an unspecified malfunction occurred.On (b)(6) 2022 it was reported via social media by the patient¿s wife that ¿sometimes the device will not alarm, as it did twice with my husband when his overnight levels got so low (20's) he collapsed and had to be rushed to the hospital.¿ based on the low bg value, the description of collapsing is presumed to mean a loss of consciousness.Since no patient or reporter contact information is available, no additional details could be obtained regarding the patient, additional symptoms, treatment, cgm values, bg values, patient outcome, or the details of the failure mode.No product or data was provided for investigation.The allegation and probable cause could not be determined.No additional patient or event information is available.

• 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: 16142978
• MDR Text Key: 307150607
• Report Number: 3004753838-2023-009799
• Device Sequence Number: 1
• Product Code: QDK
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: STR-OR-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2022
• 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): Other; Life Threatening
• Patient Sex: Male