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

Catalog Number	STK-SD-001
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Hypoglycemia (1912); Syncope/Fainting (4411)
Date of Event	04/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an unexpected receiver shutdown occurred.On the day of the event, the receiver shut off unexpectedly and the patient was not able to turn it on.The patient had no available bg meter to check her blood glucose readings and only relied on the dexcom cgm.Without a display device, she was not able to check and monitor her glucose readings.The patient experienced unspecified hypoglycemia symptoms and syncope with loss of consciousness.The patient was discovered by the daughter and transported to the emergency department.The patient did not know what medications were given to her by the hospital.She was able to go home at 6:20pm.There was no information of a bg value for the entire episode.At the time of the report, the patient was doing fine.No product or data was provided for evaluation.The allegation and a probable cause could not be determined.No additional patient or event information is available.
Additional Manufacturer Narrative
(b)(4).Diabetes mellitus is a known cause of hypoglycemia.

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: 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: 19378729
• Report Number: 3004753838-2024-123400
• Device Sequence Number: 7724874
• Product Code: QBJ
• UDI-Device Identifier: 10386270000320
• UDI-Public: 10386270000320
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: DEN170088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: STK-SD-001
• Device Lot Number: 5250377
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 54 KG