MAUDE Adverse Event Report: DEXCOM G5 RECEIVER

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 07/29/2016

Event Type  Injury  

Event Description

The dexcom receiver malfunctions and the speaker doesn't notify me (the patient) when blood glucose levels are low or high.This is particularly alarming when low because i am slightly dependent on this device to notify them when a low or high event occurs.Several seizures have occurred because of this defect and dexcom doesn't seem in any hurry to fix the problem.When i called dexcom about the issue they admitted that they are aware of defect and it was reported to the fda.I am still waiting for my receiver to come in the mail and it is going on week 2.I feel vulnerable, especially when my sugars are low because i have come accustomed to the alerts when my sugar is dropping.

• Brand Name: G5 RECEIVER
• Type of Device: G5 RECEIVER
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 5846119
• MDR Text Key: 51256148
• Report Number: MW5063829
• Device Sequence Number: 1
• Product Code: MDS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 77