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

Model Number	9438-06
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a "pair new transmitter" message occurred.Data was evaluated and the allegation was confirmed as a "pair new transmitter" message was confirmed.The probable cause was determined to be a transmitter failed error.The reported event of a "pair new transmitter" message is reportable based on the finding of a transmitter failed error.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).3004753838-2020-153123 was reported in error.Please disregard initial reporting of this event as this event has now been deemed not reportable.
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.

• 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
• MDR Report Key: 10983952
• Report Number: 3004753838-2020-153123
• Device Sequence Number: 10960236
• Product Code: PQF
• UDI-Device Identifier: 00386270000620
• UDI-Public: 00386270000620
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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: 9438-06
• Device Catalogue Number: STT-MC-001
• Device Lot Number: 7260095
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 86