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

Model Number	9500-161
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that signal loss occurred.Performance data was reviewed.The allegation was confirmed, due to the finding of signal loss over an hour within the investigation window.The probable cause was the transmitter and app were unable to establish a connection.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that signal loss occurred.Product was provided for investigation.An external visual inspection was performed and passed.Performance data was reviewed.The allegation was confirmed due to the finding of signal loss over an hour within the investigation window.The probable cause was the transmitter and app were unable to establish a connection.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).B5: describe event or problem - additional information.D4: serial no - correction.D9: device returned to mfr - additional information.D9: date device returned - additional information.H2 type of follow up: additional information/ device evaluation/ correction.H3: device evaluated by mfg- additional information.H3: evaluation included - additional information.H6: additional information.

• 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: 20845794
• Report Number: 3004753838-2024-317604
• Device Sequence Number: 8100683
• Product Code: QBJ
• UDI-Device Identifier: 00386270003416
• UDI-Public: 00386270003416
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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
• Report Date (Section B): 01/08/2025

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 Expiration Date: 09/30/2025
• Device Model Number: 9500-161
• Device Catalogue Number: STP-AT-011
• Device Lot Number: 1824108002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TANDEM T SLIM X2 INSULIN PUMP
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 100 KG