MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	MT26403-0
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that unexpected receiver shutdown occurred.It was indicated that the receiver was exposed to moisture, which is misuse of the device.No product or data was provided for evaluation.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.
Event or Problem Description
Subsequent to the initial mdr, it was determined that a report was submitted in error.Upon further review, it was determined that the patient allegation does not meet the criteria of a reportable event.
Additional Manufacturer Narrative
(b)(4).Was reported in error.Please disregard initial reporting of this event as this event has now been deemed not reportable.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent to the initial mdr, additional information has been received.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent to the initial mdr, additional information has been received.

• Brand Name: DEXCOM G7 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: 17552388
• Report Number: 3004753838-2023-161398
• Device Sequence Number: 15127194
• Product Code: QBJ
• UDI-Device Identifier: 00386270002174
• UDI-Public: 00386270002174
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K213919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MT26403-0
• Device Catalogue Number: STK-AT-012
• Device Lot Number: P15922306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 10/16/2023; 10/16/2023; 08/03/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 11/04/2023; 11/04/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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
• Patient Age: 18 YR
• Patient Sex: Female