MAUDE Adverse Event Report: DEXCOM, INC. T:SLIM G4 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number	9438-05
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the tandem user guide, the system is intended for use in an electromagnetic environment typically found in the home, at work, retail stores, and places of leisure, where daily activities occur.For specific concerns about a particular rf transmitter interfering with your system¿s operation.Please contact the cgm transmitter manufacturer for its rated power and frequency.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 an unspecified duration of time.Reportedly, the customer was around a radio wave tower, and connection is regained once leaving.No additional patient information was available.

• Brand Name: T:SLIM G4 SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 10718050
• Report Number: 3013756811-2020-115521
• Device Sequence Number: 16922068
• Product Code: OYC
• UDI-Device Identifier: 10386270000047
• UDI-Public: (01)10386270000047
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140015
• 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): 10/22/2020

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: 9438-05
• Device Catalogue Number: STT-GL-003
• 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: 09/30/2020
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR