MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	9438-06
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that signal loss over one hour occurred.Data was received for evaluation.However, the alleged product is not present within the investigation window.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that signal loss over one hour occurred.The product was evaluated.An external visual inspection was performed and passed.Perform voltage test was performed and passed.Nordic bluetooth pairing test was performed and passed.A review of the bin file was performed and signal loss was not found within the investigation window.However, the device operated within specification.The allegation was not confirmed.The probable cause could not be determined.No injury or medical intervention was reported.

• Brand Name: DEXCOM G5 MOBILE 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: 15422292
• Report Number: 3004753838-2022-170078
• Device Sequence Number: 2545015
• Product Code: PQF
• UDI-Device Identifier: 00386270000224
• UDI-Public: 00386270000224
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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 Expiration Date: 11/07/2022
• Device Model Number: 9438-06
• Device Catalogue Number: STT-GF-004
• Device Lot Number: 5310079
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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: 43 YR
• Patient Sex: Female