MAUDE Adverse Event Report: DEXCOM DEXCOM RECEIVER

Model Number MT22719

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/16/2016

Event Type  malfunction  

Event Description

Please note no self adverse events occurred.I'm only reporting device quality concerns.I have had my third dexcom cgm g5 device malfunction and become non-usable since (b)(6) 2015.Two resulted in the device reporting an error code and one resulted in the device simply not working at all.Having to get a fourth device in three months seems unreasonable to me.Particularly more discouraging is dexcom's 24-hour support line that today, resulted in a 49-minute wait until a live person answered the phone.My past calls have all resulted in wait times of minimum of 15 minutes.I realize this line is not intended for emergencies, but even for technical support for a regulated device that seems quite unreasonable.

• Brand Name: DEXCOM RECEIVER
• Type of Device: DEXCOM RECEIVER
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 5513398
• MDR Text Key: 40838979
• Report Number: MW5060953
• Device Sequence Number: 1
• Product Code: MDS
• 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: 03/16/2016

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
• Device Operator: Lay User/Patient
• Device Model Number: MT22719
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 79