MAUDE Adverse Event Report: DEXCOM DEXCOM 4G RECEIVER

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problems Fall (1848); Head Injury (1879); Hypoglycemia (1912); Loss of consciousness (2418); Ambulation Difficulties (2544)

Event Date 11/22/2014

Event Type  Injury  

Event Description

In (b)(6), i reported to dexcom that i had a problem with my dexcom transmitter and receiver.I am diabetic.My blood sugar was extremely low and i had trouble walking.The dexcom did not alarm as it should have.I had to treat my low blood sugar.About 1/2 hour later, it finally alerted me that i had low blood sugar, but i had already treated it.I also told them that my alert signals that the dexcom could play would only vibrate.I tried every loud sounding option, but it would only vibrate.I called dexcom and they said they were going to report this to the fda.I am not sure if you received this complaint from them.They told me that i needed a new transmitter/receiver.However, after looking up my information, they told me that i had to go through the (b)(6).So i called the (b)(6).They told me that was not true.They said dexcom should replace it.They put me on hold for 1/2 hour, but i had to go back to work.I am not sure why they could not work this out without me.Dexcom and (b)(6) should have decided who would be sending me a new transmitter/receiver.This past (b)(6), i got extremely low at 3 am.I did not hear it because it only vibrated.My friend was with me and idd not hear it either.I tried to get up and fell and hit my head.At 7:15 am, my friend noticed that i was not waking up and there was something wrong.He poured 3 packs of sugar under my tongue.I finally started coming around and my blood sugar was 29.This means i was less than this for over 4 hours and i was not alerted because of a malfunctioning dexcom that should have been replaced.I could have died without my friend finding me like this.I also have a black eye from falling when i tried to get up.

• Brand Name: DEXCOM 4G RECEIVER
• Type of Device: RECEIVER
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 4284323
• MDR Text Key: 18732247
• Report Number: MW5039294
• Device Sequence Number: 2
• Product Code: DXH
• 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: 11/22/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 54