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

Model Number	9438-06
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the transmitter lost connection with the pump for over 1 hour.No additional patient information was available.During a follow-up, it was reported that issue had been resolved.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 10123903
• Report Number: 3013756811-2020-56575
• Device Sequence Number: 2680907
• Product Code: MDS
• UDI-Device Identifier: 00386270000040
• UDI-Public: 00386270000040
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2020

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-GF-005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2020
• Initial Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR