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	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the tandem user guide: "the transmitter battery will last at least 6 months.Once you see the low transmitter battery alert, replace the transmitter as soon as possible:" 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 greater than 1 hour.Reportedly, the transmitter had been in use longer than 6 months.Multiple contact attempts were made by tandem technical support to obtain additional information regarding the issue; however, the customer did not respond.No additional patient or event 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: 10253418
• Report Number: 3013756811-2020-68317
• Device Sequence Number: 16272293
• Product Code: OYC
• UDI-Device Identifier: 10386270000047
• UDI-Public: (01)10386270000047
• Combination Product (Y/N): N
• 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): 07/09/2020

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: 06/16/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 77