MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSORS ; SENSOR, GLUCOSE, INVASIVE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2020

Event Type  Injury  

Event Description

Caller stated that he is having problems with his sensors.Lately he is getting error messages on the device when the sensor is used even before the two (2) window for the it to warm up an error message appears.He said one sensor supposed to last ten (10) days so far he has used eight (8) sensors within a week.He is currently on his 9th sensor and is within the two hours warming window and hoping there will be no error message.He called the technical support, left messages and they only returned his call once and was told new sensors will be delivered to him.He doesn't understand what is wrong is either the sensor or the transmitter is bad.Mfr keeps sending sensors and the pump keeps giving error messages.

• Brand Name: DEXCOM G6 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 9733687
• MDR Text Key: 180618290
• Report Number: MW5093138
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/19/2020
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 130