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

Model Number	9438-06
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received and evaluation is performed.
Event or Problem Description
It was reported that the customer received a failed transmitter error.The transmitter had been in use less than three months.No additional patient or event information was available.A root cause could not be determined.A replacement transmitter was sent to the customer.

• 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: 9910296
• Report Number: 3013756811-2020-30331
• Device Sequence Number: 3131677
• Product Code: MDS
• UDI-Device Identifier: 00386270000040
• UDI-Public: 00386270000040
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/01/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 34